Neonatal Medicine

SAN DIEGO — Maternal hidradenitis suppurativa (HS) is associated with an increased risk for adverse birth outcomes and childhood morbidities, including respiratory, metabolic, central nervous system, and other conditions.

Those are key findings from a longitudinal cohort study that was presented during a poster session at the annual meeting of the American Academy of Dermatology.

“HS is associated with morbidity in women of reproductive age and adverse pregnancy outcomes, [but] its effect on offspring outcomes remains unclear,” corresponding author Kaiyang Li, a third-year medical student at McGill University, Quebec, Canada, and coauthors wrote in their abstract.

To investigate the association between maternal HS and offspring outcomes at birth and with up to 16 years of follow-up, the researchers drew from a longitudinal cohort of 1,275,593 children born in Quebec between April 1, 2006 and March 31, 2022. They matched children with their mothers and used identification numbers to follow the children to note morbidities that led to hospital admissions before age 16 years. The exposure of interest was HS, and the main outcome measure was childhood hospitalizations for respiratory, cardiovascular, metabolic, and other morbidities prior to age 16 years. 

Next, they estimated hazard ratios (HR) and 95% CIs for the association of maternal HS with childhood morbidity in adjusted Cox proportional hazards regression models. “As prenatal exposure to hyperandrogenism may influence boys and girls differently, we carried out subgroup analyses stratified by child sex,” they wrote. 

The study population included 1283 children whose mothers had HS and 1,274,310 unexposed children. As for infant outcomes, compared with no exposure, maternal HS was associated with an increased risk for preterm birth (relative risk [RR], 1.29; 95% CI, 1,08-1.55), neonatal death (RR, 2.07; 95% CI, 1.03-14.13), birth defects (RR, 1.29; 95% CI, 1.07-1.56), congenital heart defects (RR, 1.57; 95% CI, 1.02-2.44), and orofacial defects (RR 4.29; 95% CI, 1.85-9.97).

As for long-term outcomes in the children, compared with those whose mothers did not have HS, maternal HS was associated with an increased risk for any childhood hospitalization (HR, 1.31; 95% CI, 1.19-1.44), respiratory hospitalization (HR, 1.21; 95% CI, 1.05-1.40), metabolic hospitalization (HR, 2.64; 95% CI, 1.67-4.20), gastrointestinal hospitalization (HR, 1.34; 95% CI, 1.03-1.74), and developmental hospitalization (HR, 1.92; 95% CI, 1.43-2.58).

Commenting on the results after the meeting, Ms. Li said that the findings support the need for timely management of HS in expectant mothers and people planning to conceive, and for “interdisciplinary care and follow up for both the mother and the baby, involving the dermatologist, the obstetrician, and the neonatologist or pediatrician if needed.”

“HS is a multidisciplinary disease, plain and simple,” Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, who was asked to comment on the study, said in an interview. “This study highlights the importance of collaboration between dermatology and obstetrician-gynecologist given the potential negative pregnancy outcomes, but to me raising alarm bells given the known gaps and delays in diagnosis matched to disease onset,” said Dr. Friedman, who was not involved with the study. “We need to do better to ensure the safety of both patient and patient-to-be.”

The researchers reported having no financial disclosures. The abstract was selected as the second-place winner in the AAD’s poster competition. Dr. Friedman has no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — Maternal hidradenitis suppurativa (HS) is associated with an increased risk for adverse birth outcomes and childhood morbidities, including respiratory, metabolic, central nervous system, and other conditions.

Those are key findings from a longitudinal cohort study that was presented during a poster session at the annual meeting of the American Academy of Dermatology.

“HS is associated with morbidity in women of reproductive age and adverse pregnancy outcomes, [but] its effect on offspring outcomes remains unclear,” corresponding author Kaiyang Li, a third-year medical student at McGill University, Quebec, Canada, and coauthors wrote in their abstract.

To investigate the association between maternal HS and offspring outcomes at birth and with up to 16 years of follow-up, the researchers drew from a longitudinal cohort of 1,275,593 children born in Quebec between April 1, 2006 and March 31, 2022. They matched children with their mothers and used identification numbers to follow the children to note morbidities that led to hospital admissions before age 16 years. The exposure of interest was HS, and the main outcome measure was childhood hospitalizations for respiratory, cardiovascular, metabolic, and other morbidities prior to age 16 years. 

Next, they estimated hazard ratios (HR) and 95% CIs for the association of maternal HS with childhood morbidity in adjusted Cox proportional hazards regression models. “As prenatal exposure to hyperandrogenism may influence boys and girls differently, we carried out subgroup analyses stratified by child sex,” they wrote. 

The study population included 1283 children whose mothers had HS and 1,274,310 unexposed children. As for infant outcomes, compared with no exposure, maternal HS was associated with an increased risk for preterm birth (relative risk [RR], 1.29; 95% CI, 1,08-1.55), neonatal death (RR, 2.07; 95% CI, 1.03-14.13), birth defects (RR, 1.29; 95% CI, 1.07-1.56), congenital heart defects (RR, 1.57; 95% CI, 1.02-2.44), and orofacial defects (RR 4.29; 95% CI, 1.85-9.97).

As for long-term outcomes in the children, compared with those whose mothers did not have HS, maternal HS was associated with an increased risk for any childhood hospitalization (HR, 1.31; 95% CI, 1.19-1.44), respiratory hospitalization (HR, 1.21; 95% CI, 1.05-1.40), metabolic hospitalization (HR, 2.64; 95% CI, 1.67-4.20), gastrointestinal hospitalization (HR, 1.34; 95% CI, 1.03-1.74), and developmental hospitalization (HR, 1.92; 95% CI, 1.43-2.58).

Commenting on the results after the meeting, Ms. Li said that the findings support the need for timely management of HS in expectant mothers and people planning to conceive, and for “interdisciplinary care and follow up for both the mother and the baby, involving the dermatologist, the obstetrician, and the neonatologist or pediatrician if needed.”

“HS is a multidisciplinary disease, plain and simple,” Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, who was asked to comment on the study, said in an interview. “This study highlights the importance of collaboration between dermatology and obstetrician-gynecologist given the potential negative pregnancy outcomes, but to me raising alarm bells given the known gaps and delays in diagnosis matched to disease onset,” said Dr. Friedman, who was not involved with the study. “We need to do better to ensure the safety of both patient and patient-to-be.”

The researchers reported having no financial disclosures. The abstract was selected as the second-place winner in the AAD’s poster competition. Dr. Friedman has no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — Maternal hidradenitis suppurativa (HS) is associated with an increased risk for adverse birth outcomes and childhood morbidities, including respiratory, metabolic, central nervous system, and other conditions.

Those are key findings from a longitudinal cohort study that was presented during a poster session at the annual meeting of the American Academy of Dermatology.

“HS is associated with morbidity in women of reproductive age and adverse pregnancy outcomes, [but] its effect on offspring outcomes remains unclear,” corresponding author Kaiyang Li, a third-year medical student at McGill University, Quebec, Canada, and coauthors wrote in their abstract.

To investigate the association between maternal HS and offspring outcomes at birth and with up to 16 years of follow-up, the researchers drew from a longitudinal cohort of 1,275,593 children born in Quebec between April 1, 2006 and March 31, 2022. They matched children with their mothers and used identification numbers to follow the children to note morbidities that led to hospital admissions before age 16 years. The exposure of interest was HS, and the main outcome measure was childhood hospitalizations for respiratory, cardiovascular, metabolic, and other morbidities prior to age 16 years. 

Next, they estimated hazard ratios (HR) and 95% CIs for the association of maternal HS with childhood morbidity in adjusted Cox proportional hazards regression models. “As prenatal exposure to hyperandrogenism may influence boys and girls differently, we carried out subgroup analyses stratified by child sex,” they wrote. 

The study population included 1283 children whose mothers had HS and 1,274,310 unexposed children. As for infant outcomes, compared with no exposure, maternal HS was associated with an increased risk for preterm birth (relative risk [RR], 1.29; 95% CI, 1,08-1.55), neonatal death (RR, 2.07; 95% CI, 1.03-14.13), birth defects (RR, 1.29; 95% CI, 1.07-1.56), congenital heart defects (RR, 1.57; 95% CI, 1.02-2.44), and orofacial defects (RR 4.29; 95% CI, 1.85-9.97).

As for long-term outcomes in the children, compared with those whose mothers did not have HS, maternal HS was associated with an increased risk for any childhood hospitalization (HR, 1.31; 95% CI, 1.19-1.44), respiratory hospitalization (HR, 1.21; 95% CI, 1.05-1.40), metabolic hospitalization (HR, 2.64; 95% CI, 1.67-4.20), gastrointestinal hospitalization (HR, 1.34; 95% CI, 1.03-1.74), and developmental hospitalization (HR, 1.92; 95% CI, 1.43-2.58).

Commenting on the results after the meeting, Ms. Li said that the findings support the need for timely management of HS in expectant mothers and people planning to conceive, and for “interdisciplinary care and follow up for both the mother and the baby, involving the dermatologist, the obstetrician, and the neonatologist or pediatrician if needed.”

“HS is a multidisciplinary disease, plain and simple,” Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, who was asked to comment on the study, said in an interview. “This study highlights the importance of collaboration between dermatology and obstetrician-gynecologist given the potential negative pregnancy outcomes, but to me raising alarm bells given the known gaps and delays in diagnosis matched to disease onset,” said Dr. Friedman, who was not involved with the study. “We need to do better to ensure the safety of both patient and patient-to-be.”

The researchers reported having no financial disclosures. The abstract was selected as the second-place winner in the AAD’s poster competition. Dr. Friedman has no relevant disclosures.

A version of this article appeared on Medscape.com.

With rates of syphilis rising quickly in the United States and elsewhere, clinicians are having to up their game when it comes to diagnosing and treating an infection that they may not be paying enough attention to.

More than 200,000 cases of syphilis were reported in the United States in 2022, which is the highest number since 1950 and is a 17.3% increase over 2021, according to the latest figures from the Centers for Disease Control and Prevention (CDC). The rate of infection has increased almost every year since a historic low in 2001.

And the trend is not limited to the United States. Last year, the infection rate in the United Kingdom hit a 50-year high, said David Mabey, BCh, DM, from the London School of Hygiene and Tropical Medicine. Syphilis and other sexually transmitted infections are also a major problem in low- and middle-income countries, he added, although good data are not always available.

Many of today’s healthcare professionals have little experience with the disease, shared Ina Park, MD, a sexually transmitted infections specialist at the University of California at San Francisco. “An entire generation of physicians — including myself — did not see any cases until we were well out of our training,” Dr. Park reported. “We’re really playing catch-up.”
 

A Centuries-Old Ailment

Dr. Park offered some advice on the challenges of diagnosing what can be an elusive infection at the Conference on Retroviruses and Opportunistic Infections (CROI) 2024 Annual Meeting in Denver. That advice boiled down to one simple rule: “Test, test, test.”

Because syphilis can mimic so many other conditions and can have long periods of latency, it can be easily missed or even misdiagnosed by experienced physicians, said Dr. Park. Clinicians need to keep it front of mind and have a lower threshold for testing, even if there are no obvious symptoms.

Following the CDC’s new recommendations for syphilis screening will help, she noted; every sexually active patient aged between 15 and 44 years who lives in a county with a syphilis infection rate of 4.6 per 100,000 people or higher should get the test. And clinicians should remain vigilant, even in areas with a lower prevalence. “If you can’t account for new symptoms in a sexually active patient, order a test,” said Dr. Park.
 

Complicated Cases

The lack of experience with syphilis affects not just diagnosis but also treatment, particularly for complex cases, said Khalil Ghanem, MD, PhD, from the Johns Hopkins University School of Medicine in Baltimore. “When you don’t have to deal with something for a while, you forget how to deal with it,” he added.

At CROI, Dr. Ghanem offered suggestions for how to navigate complicated cases of ocular syphilis, otic syphilis, and neurosyphilis, and how to interpret test results when a patient’s antigen titers are being “unruly.”

With potential ocular or otic syphilis, you shouldn’t wait for a specialist like an ophthalmologist to weigh in but instead refer the patient directly to the emergency department because of the risk that the symptoms may become irreversible and result in permanent blindness or deafness. “You don’t want to dilly-dally with those conditions,” Dr. Ghanem said.

Closely monitoring a patient’s rapid plasma regain and venereal disease research laboratory antigen levels is the only way to manage syphilis and to determine whether the infection is responding to treatment, he noted, but sometimes those titers “don’t do what you think they should be doing” and fail to decline or even go up after treatment.

“You don’t know if they went up because the patient was re-infected, or they developed neurosyphilis, or there was a problem at the lab,” he said. “It can be challenging to interpret.”

To decipher confusing test results, Dr. Ghanem recommended getting a detailed history to understand whether a patient is at risk for reinfection, whether there are signs of neurosyphilis or other complications, whether pregnancy is possible, and so on. “Based on the answers, you can determine what the most rational approach to treatment would be,” he shared.
 

Drug Shortages

Efforts to get the infection under control have become more complicated. Last summer, Pfizer announced that it had run out of penicillin G benzathine (Bicillin), an injectable, long-acting drug that is one of the main treatments for syphilis and the only one that can be given to pregnant people. Supplies for children ran out at the end of June 2023, and supplies for adults were gone by the end of September.

Because Pfizer is the only company that manufactures penicillin G benzathine, there is no one to pick up the slack in the short-term, so the shortage is expected to continue until at least the middle of 2024.

In response, the US Food and Drug Administration has temporarily allowed the use of benzylpenicillin benzathine (Extencilline), a French formulation that has not been approved in the United States, until supplies of penicillin G benzathine are stabilized.

The shortage has shone a spotlight on the important issue of a lack of alternatives for the treatment of syphilis during pregnancy, which increases the risk for congenital syphilis. “Hopefully, this pushes the National Institutes of Health and others to step up their game on studies for alternative drugs for use in pregnancy,” Dr. Ghanem said.
 

A version of this article appeared on Medscape.com.

With rates of syphilis rising quickly in the United States and elsewhere, clinicians are having to up their game when it comes to diagnosing and treating an infection that they may not be paying enough attention to.

More than 200,000 cases of syphilis were reported in the United States in 2022, which is the highest number since 1950 and is a 17.3% increase over 2021, according to the latest figures from the Centers for Disease Control and Prevention (CDC). The rate of infection has increased almost every year since a historic low in 2001.

And the trend is not limited to the United States. Last year, the infection rate in the United Kingdom hit a 50-year high, said David Mabey, BCh, DM, from the London School of Hygiene and Tropical Medicine. Syphilis and other sexually transmitted infections are also a major problem in low- and middle-income countries, he added, although good data are not always available.

Many of today’s healthcare professionals have little experience with the disease, shared Ina Park, MD, a sexually transmitted infections specialist at the University of California at San Francisco. “An entire generation of physicians — including myself — did not see any cases until we were well out of our training,” Dr. Park reported. “We’re really playing catch-up.”
 

A Centuries-Old Ailment

Dr. Park offered some advice on the challenges of diagnosing what can be an elusive infection at the Conference on Retroviruses and Opportunistic Infections (CROI) 2024 Annual Meeting in Denver. That advice boiled down to one simple rule: “Test, test, test.”

Because syphilis can mimic so many other conditions and can have long periods of latency, it can be easily missed or even misdiagnosed by experienced physicians, said Dr. Park. Clinicians need to keep it front of mind and have a lower threshold for testing, even if there are no obvious symptoms.

Following the CDC’s new recommendations for syphilis screening will help, she noted; every sexually active patient aged between 15 and 44 years who lives in a county with a syphilis infection rate of 4.6 per 100,000 people or higher should get the test. And clinicians should remain vigilant, even in areas with a lower prevalence. “If you can’t account for new symptoms in a sexually active patient, order a test,” said Dr. Park.
 

Complicated Cases

The lack of experience with syphilis affects not just diagnosis but also treatment, particularly for complex cases, said Khalil Ghanem, MD, PhD, from the Johns Hopkins University School of Medicine in Baltimore. “When you don’t have to deal with something for a while, you forget how to deal with it,” he added.

At CROI, Dr. Ghanem offered suggestions for how to navigate complicated cases of ocular syphilis, otic syphilis, and neurosyphilis, and how to interpret test results when a patient’s antigen titers are being “unruly.”

With potential ocular or otic syphilis, you shouldn’t wait for a specialist like an ophthalmologist to weigh in but instead refer the patient directly to the emergency department because of the risk that the symptoms may become irreversible and result in permanent blindness or deafness. “You don’t want to dilly-dally with those conditions,” Dr. Ghanem said.

Closely monitoring a patient’s rapid plasma regain and venereal disease research laboratory antigen levels is the only way to manage syphilis and to determine whether the infection is responding to treatment, he noted, but sometimes those titers “don’t do what you think they should be doing” and fail to decline or even go up after treatment.

“You don’t know if they went up because the patient was re-infected, or they developed neurosyphilis, or there was a problem at the lab,” he said. “It can be challenging to interpret.”

To decipher confusing test results, Dr. Ghanem recommended getting a detailed history to understand whether a patient is at risk for reinfection, whether there are signs of neurosyphilis or other complications, whether pregnancy is possible, and so on. “Based on the answers, you can determine what the most rational approach to treatment would be,” he shared.
 

Drug Shortages

Efforts to get the infection under control have become more complicated. Last summer, Pfizer announced that it had run out of penicillin G benzathine (Bicillin), an injectable, long-acting drug that is one of the main treatments for syphilis and the only one that can be given to pregnant people. Supplies for children ran out at the end of June 2023, and supplies for adults were gone by the end of September.

Because Pfizer is the only company that manufactures penicillin G benzathine, there is no one to pick up the slack in the short-term, so the shortage is expected to continue until at least the middle of 2024.

In response, the US Food and Drug Administration has temporarily allowed the use of benzylpenicillin benzathine (Extencilline), a French formulation that has not been approved in the United States, until supplies of penicillin G benzathine are stabilized.

The shortage has shone a spotlight on the important issue of a lack of alternatives for the treatment of syphilis during pregnancy, which increases the risk for congenital syphilis. “Hopefully, this pushes the National Institutes of Health and others to step up their game on studies for alternative drugs for use in pregnancy,” Dr. Ghanem said.
 

A version of this article appeared on Medscape.com.

With rates of syphilis rising quickly in the United States and elsewhere, clinicians are having to up their game when it comes to diagnosing and treating an infection that they may not be paying enough attention to.

More than 200,000 cases of syphilis were reported in the United States in 2022, which is the highest number since 1950 and is a 17.3% increase over 2021, according to the latest figures from the Centers for Disease Control and Prevention (CDC). The rate of infection has increased almost every year since a historic low in 2001.

And the trend is not limited to the United States. Last year, the infection rate in the United Kingdom hit a 50-year high, said David Mabey, BCh, DM, from the London School of Hygiene and Tropical Medicine. Syphilis and other sexually transmitted infections are also a major problem in low- and middle-income countries, he added, although good data are not always available.

Many of today’s healthcare professionals have little experience with the disease, shared Ina Park, MD, a sexually transmitted infections specialist at the University of California at San Francisco. “An entire generation of physicians — including myself — did not see any cases until we were well out of our training,” Dr. Park reported. “We’re really playing catch-up.”
 

A Centuries-Old Ailment

Dr. Park offered some advice on the challenges of diagnosing what can be an elusive infection at the Conference on Retroviruses and Opportunistic Infections (CROI) 2024 Annual Meeting in Denver. That advice boiled down to one simple rule: “Test, test, test.”

Because syphilis can mimic so many other conditions and can have long periods of latency, it can be easily missed or even misdiagnosed by experienced physicians, said Dr. Park. Clinicians need to keep it front of mind and have a lower threshold for testing, even if there are no obvious symptoms.

Following the CDC’s new recommendations for syphilis screening will help, she noted; every sexually active patient aged between 15 and 44 years who lives in a county with a syphilis infection rate of 4.6 per 100,000 people or higher should get the test. And clinicians should remain vigilant, even in areas with a lower prevalence. “If you can’t account for new symptoms in a sexually active patient, order a test,” said Dr. Park.
 

Complicated Cases

The lack of experience with syphilis affects not just diagnosis but also treatment, particularly for complex cases, said Khalil Ghanem, MD, PhD, from the Johns Hopkins University School of Medicine in Baltimore. “When you don’t have to deal with something for a while, you forget how to deal with it,” he added.

At CROI, Dr. Ghanem offered suggestions for how to navigate complicated cases of ocular syphilis, otic syphilis, and neurosyphilis, and how to interpret test results when a patient’s antigen titers are being “unruly.”

With potential ocular or otic syphilis, you shouldn’t wait for a specialist like an ophthalmologist to weigh in but instead refer the patient directly to the emergency department because of the risk that the symptoms may become irreversible and result in permanent blindness or deafness. “You don’t want to dilly-dally with those conditions,” Dr. Ghanem said.

Closely monitoring a patient’s rapid plasma regain and venereal disease research laboratory antigen levels is the only way to manage syphilis and to determine whether the infection is responding to treatment, he noted, but sometimes those titers “don’t do what you think they should be doing” and fail to decline or even go up after treatment.

“You don’t know if they went up because the patient was re-infected, or they developed neurosyphilis, or there was a problem at the lab,” he said. “It can be challenging to interpret.”

To decipher confusing test results, Dr. Ghanem recommended getting a detailed history to understand whether a patient is at risk for reinfection, whether there are signs of neurosyphilis or other complications, whether pregnancy is possible, and so on. “Based on the answers, you can determine what the most rational approach to treatment would be,” he shared.
 

Drug Shortages

Efforts to get the infection under control have become more complicated. Last summer, Pfizer announced that it had run out of penicillin G benzathine (Bicillin), an injectable, long-acting drug that is one of the main treatments for syphilis and the only one that can be given to pregnant people. Supplies for children ran out at the end of June 2023, and supplies for adults were gone by the end of September.

Because Pfizer is the only company that manufactures penicillin G benzathine, there is no one to pick up the slack in the short-term, so the shortage is expected to continue until at least the middle of 2024.

In response, the US Food and Drug Administration has temporarily allowed the use of benzylpenicillin benzathine (Extencilline), a French formulation that has not been approved in the United States, until supplies of penicillin G benzathine are stabilized.

The shortage has shone a spotlight on the important issue of a lack of alternatives for the treatment of syphilis during pregnancy, which increases the risk for congenital syphilis. “Hopefully, this pushes the National Institutes of Health and others to step up their game on studies for alternative drugs for use in pregnancy,” Dr. Ghanem said.
 

A version of this article appeared on Medscape.com.

A phase 3 trial of a maternal vaccine candidate for respiratory syncytial virus (RSV) has been stopped early because the risk for preterm births is higher in the candidate vaccine group than in the placebo group.

By the time enrollment was stopped on February 25, 2022 because of the safety signal of preterm birth, 5328 pregnant women had been vaccinated, about half of the intended 10,000 enrollees. Of these, 3557 received the candidate vaccine RSV prefusion F protein–based maternal vaccine, and another 1771 received a placebo.

Data from the trial, sponsored by GSK, were immediately made available when recruitment and vaccination were stopped, and investigation of the preterm birth risk followed. Results of that analysis, led by Ilse Dieussaert, IR, vice president for vaccine development at GSK in Wavre, Belgium, are published online on March 13 in The New England Journal of Medicine. 

“We have discontinued our work on this RSV maternal candidate vaccine, and we are closing out all ongoing trials with the exception of the MAT-015 follow-on study to monitor subsequent pregnancies,” a GSK spokesperson said in an interview.

The trial was conducted in pregnant women aged 18-49 years to assess the efficacy and safety of the vaccine. The women were randomly assigned 2:1 to receive the candidate vaccine or placebo between 24 and 34 weeks’ gestation.
 

Preterm Births

The primary outcomes were any or severe medically assessed RSV-associated lower respiratory tract infection in infants from birth to 6 months and safety in infants from birth to 12 months.

According to the data, preterm birth occurred in 6.8% of the infants in the vaccine group and in 4.9% of those in the placebo group (relative risk [RR], 1.37; 95% CI, 1.08-1.74; P = .01). Neonatal death occurred in 0.4% in the vaccine group and 0.2% in the placebo group (RR, 2.16; 95% CI, 0.62-7.56; P = .23).

To date, only one RSV vaccine (Abrysvo, Pfizer) has been approved for use during pregnancy to protect infants from RSV-associated lower respiratory tract infection.

“It was a very big deal that this trial was stopped, and the new candidate won’t get approval.” said Aaron E. Glatt, MD, chair of the Department of Medicine and chief of Infectious Diseases and Hospital Epidemiologist at Mount Sinai South Nassau in Oceanside, New York.
 

Only One RSV Vaccine Approved in Pregnancy

Dr. Glatt pointed out the GSK vaccine is like the maternal vaccine that did get approved. “The data clearly show that there was a slight but increased risk in preterm labor,” Dr. Glatt said, “and while not as clearly shown, there was an increase in neonatal death in the group of very small numbers, but any neonatal death is of concern.”

The implications were disturbing, he added, “You’re giving this vaccine to prevent neonatal death.” Though the Pfizer vaccine that was granted approval had a very slight increase in premature birth, the risk wasn’t statistically significant, he pointed out, “and it showed similar benefits in preventing neonatal illness, which can be fatal.”

Dr. Glatt said that there is still a lingering concern with the approved vaccine, and he explained that most clinicians will give it closer to the end of the recommended time window of 34 weeks. “This way, even if there is a slight increase in premature term labor, you’re probably not going to have a serious outcome because the baby will be far enough along.”

A difference in the incidence of preterm birth between the experimental vaccine and placebo groups was predominantly found in low- and middle-income countries, according to Dieussaert’s team, “where approximately 50% of the trial population was enrolled and where the medical need for maternal RSV vaccines is the greatest.”

The RR was 1.56 (95% CI, 1.17-2.10) for low- and middle-income countries and 1.04 (95% CI, 0.68-1.58) for high-income countries. 

“If a smaller percentage of participants from low- and middle-income countries had been enrolled in our trial, the RR for preterm birth in the vaccine group as compared with the placebo group might have been reduced in the overall trial population,” they reported.

The authors explained that the data do not reveal the cause of the higher risk for preterm birth in the vaccine group.

“We do not know what caused the signal,” the company’s spokesperson added. “GSK completed all the necessary steps of product development including preclinical toxicology studies and clinical studies in nonpregnant women prior to starting the studies in pregnant women. There were no safety signals identified in any of the earlier parts of the clinical testing. There have been no safety signals identified in the other phase 3 trials for this vaccine candidate.”

Researchers did not find a correlation between preterm births in the treatment vs control groups with gestational age at the time of vaccination or with particular vaccine clinical trial material lots, race, ethnicity, maternal smoking, alcohol consumption, body mass index, or time between study vaccination and delivery, the GSK spokesperson said.

The spokesperson noted that the halted vaccine is different from GSK’s currently approved adjuvanted RSV vaccine (Arexvy) for adults aged 60 years or older.

What’s Next for Other Vaccines

Maternal vaccines have been effective in preventing other diseases in infants, such as tetanus, influenza, and pertussis, but RSV is a very hard virus to make a vaccine for, Dr. Glatt shared.

The need is great to have more than one option for a maternal RSV vaccine, he added, to address any potential supply concerns.

“People have to realize how serious RSV can be in infants,” he said. “It can be a fatal disease. This can be a serious illness even in healthy children.”

A version of this article appeared on Medscape.com.

A phase 3 trial of a maternal vaccine candidate for respiratory syncytial virus (RSV) has been stopped early because the risk for preterm births is higher in the candidate vaccine group than in the placebo group.

By the time enrollment was stopped on February 25, 2022 because of the safety signal of preterm birth, 5328 pregnant women had been vaccinated, about half of the intended 10,000 enrollees. Of these, 3557 received the candidate vaccine RSV prefusion F protein–based maternal vaccine, and another 1771 received a placebo.

Data from the trial, sponsored by GSK, were immediately made available when recruitment and vaccination were stopped, and investigation of the preterm birth risk followed. Results of that analysis, led by Ilse Dieussaert, IR, vice president for vaccine development at GSK in Wavre, Belgium, are published online on March 13 in The New England Journal of Medicine. 

“We have discontinued our work on this RSV maternal candidate vaccine, and we are closing out all ongoing trials with the exception of the MAT-015 follow-on study to monitor subsequent pregnancies,” a GSK spokesperson said in an interview.

The trial was conducted in pregnant women aged 18-49 years to assess the efficacy and safety of the vaccine. The women were randomly assigned 2:1 to receive the candidate vaccine or placebo between 24 and 34 weeks’ gestation.
 

Preterm Births

The primary outcomes were any or severe medically assessed RSV-associated lower respiratory tract infection in infants from birth to 6 months and safety in infants from birth to 12 months.

According to the data, preterm birth occurred in 6.8% of the infants in the vaccine group and in 4.9% of those in the placebo group (relative risk [RR], 1.37; 95% CI, 1.08-1.74; P = .01). Neonatal death occurred in 0.4% in the vaccine group and 0.2% in the placebo group (RR, 2.16; 95% CI, 0.62-7.56; P = .23).

To date, only one RSV vaccine (Abrysvo, Pfizer) has been approved for use during pregnancy to protect infants from RSV-associated lower respiratory tract infection.

“It was a very big deal that this trial was stopped, and the new candidate won’t get approval.” said Aaron E. Glatt, MD, chair of the Department of Medicine and chief of Infectious Diseases and Hospital Epidemiologist at Mount Sinai South Nassau in Oceanside, New York.
 

Only One RSV Vaccine Approved in Pregnancy

Dr. Glatt pointed out the GSK vaccine is like the maternal vaccine that did get approved. “The data clearly show that there was a slight but increased risk in preterm labor,” Dr. Glatt said, “and while not as clearly shown, there was an increase in neonatal death in the group of very small numbers, but any neonatal death is of concern.”

The implications were disturbing, he added, “You’re giving this vaccine to prevent neonatal death.” Though the Pfizer vaccine that was granted approval had a very slight increase in premature birth, the risk wasn’t statistically significant, he pointed out, “and it showed similar benefits in preventing neonatal illness, which can be fatal.”

Dr. Glatt said that there is still a lingering concern with the approved vaccine, and he explained that most clinicians will give it closer to the end of the recommended time window of 34 weeks. “This way, even if there is a slight increase in premature term labor, you’re probably not going to have a serious outcome because the baby will be far enough along.”

A difference in the incidence of preterm birth between the experimental vaccine and placebo groups was predominantly found in low- and middle-income countries, according to Dieussaert’s team, “where approximately 50% of the trial population was enrolled and where the medical need for maternal RSV vaccines is the greatest.”

The RR was 1.56 (95% CI, 1.17-2.10) for low- and middle-income countries and 1.04 (95% CI, 0.68-1.58) for high-income countries. 

“If a smaller percentage of participants from low- and middle-income countries had been enrolled in our trial, the RR for preterm birth in the vaccine group as compared with the placebo group might have been reduced in the overall trial population,” they reported.

The authors explained that the data do not reveal the cause of the higher risk for preterm birth in the vaccine group.

“We do not know what caused the signal,” the company’s spokesperson added. “GSK completed all the necessary steps of product development including preclinical toxicology studies and clinical studies in nonpregnant women prior to starting the studies in pregnant women. There were no safety signals identified in any of the earlier parts of the clinical testing. There have been no safety signals identified in the other phase 3 trials for this vaccine candidate.”

Researchers did not find a correlation between preterm births in the treatment vs control groups with gestational age at the time of vaccination or with particular vaccine clinical trial material lots, race, ethnicity, maternal smoking, alcohol consumption, body mass index, or time between study vaccination and delivery, the GSK spokesperson said.

The spokesperson noted that the halted vaccine is different from GSK’s currently approved adjuvanted RSV vaccine (Arexvy) for adults aged 60 years or older.

What’s Next for Other Vaccines

Maternal vaccines have been effective in preventing other diseases in infants, such as tetanus, influenza, and pertussis, but RSV is a very hard virus to make a vaccine for, Dr. Glatt shared.

The need is great to have more than one option for a maternal RSV vaccine, he added, to address any potential supply concerns.

“People have to realize how serious RSV can be in infants,” he said. “It can be a fatal disease. This can be a serious illness even in healthy children.”

A version of this article appeared on Medscape.com.

A phase 3 trial of a maternal vaccine candidate for respiratory syncytial virus (RSV) has been stopped early because the risk for preterm births is higher in the candidate vaccine group than in the placebo group.

By the time enrollment was stopped on February 25, 2022 because of the safety signal of preterm birth, 5328 pregnant women had been vaccinated, about half of the intended 10,000 enrollees. Of these, 3557 received the candidate vaccine RSV prefusion F protein–based maternal vaccine, and another 1771 received a placebo.

Data from the trial, sponsored by GSK, were immediately made available when recruitment and vaccination were stopped, and investigation of the preterm birth risk followed. Results of that analysis, led by Ilse Dieussaert, IR, vice president for vaccine development at GSK in Wavre, Belgium, are published online on March 13 in The New England Journal of Medicine. 

“We have discontinued our work on this RSV maternal candidate vaccine, and we are closing out all ongoing trials with the exception of the MAT-015 follow-on study to monitor subsequent pregnancies,” a GSK spokesperson said in an interview.

The trial was conducted in pregnant women aged 18-49 years to assess the efficacy and safety of the vaccine. The women were randomly assigned 2:1 to receive the candidate vaccine or placebo between 24 and 34 weeks’ gestation.
 

Preterm Births

The primary outcomes were any or severe medically assessed RSV-associated lower respiratory tract infection in infants from birth to 6 months and safety in infants from birth to 12 months.

According to the data, preterm birth occurred in 6.8% of the infants in the vaccine group and in 4.9% of those in the placebo group (relative risk [RR], 1.37; 95% CI, 1.08-1.74; P = .01). Neonatal death occurred in 0.4% in the vaccine group and 0.2% in the placebo group (RR, 2.16; 95% CI, 0.62-7.56; P = .23).

To date, only one RSV vaccine (Abrysvo, Pfizer) has been approved for use during pregnancy to protect infants from RSV-associated lower respiratory tract infection.

“It was a very big deal that this trial was stopped, and the new candidate won’t get approval.” said Aaron E. Glatt, MD, chair of the Department of Medicine and chief of Infectious Diseases and Hospital Epidemiologist at Mount Sinai South Nassau in Oceanside, New York.
 

Only One RSV Vaccine Approved in Pregnancy

Dr. Glatt pointed out the GSK vaccine is like the maternal vaccine that did get approved. “The data clearly show that there was a slight but increased risk in preterm labor,” Dr. Glatt said, “and while not as clearly shown, there was an increase in neonatal death in the group of very small numbers, but any neonatal death is of concern.”

The implications were disturbing, he added, “You’re giving this vaccine to prevent neonatal death.” Though the Pfizer vaccine that was granted approval had a very slight increase in premature birth, the risk wasn’t statistically significant, he pointed out, “and it showed similar benefits in preventing neonatal illness, which can be fatal.”

Dr. Glatt said that there is still a lingering concern with the approved vaccine, and he explained that most clinicians will give it closer to the end of the recommended time window of 34 weeks. “This way, even if there is a slight increase in premature term labor, you’re probably not going to have a serious outcome because the baby will be far enough along.”

A difference in the incidence of preterm birth between the experimental vaccine and placebo groups was predominantly found in low- and middle-income countries, according to Dieussaert’s team, “where approximately 50% of the trial population was enrolled and where the medical need for maternal RSV vaccines is the greatest.”

The RR was 1.56 (95% CI, 1.17-2.10) for low- and middle-income countries and 1.04 (95% CI, 0.68-1.58) for high-income countries. 

“If a smaller percentage of participants from low- and middle-income countries had been enrolled in our trial, the RR for preterm birth in the vaccine group as compared with the placebo group might have been reduced in the overall trial population,” they reported.

The authors explained that the data do not reveal the cause of the higher risk for preterm birth in the vaccine group.

“We do not know what caused the signal,” the company’s spokesperson added. “GSK completed all the necessary steps of product development including preclinical toxicology studies and clinical studies in nonpregnant women prior to starting the studies in pregnant women. There were no safety signals identified in any of the earlier parts of the clinical testing. There have been no safety signals identified in the other phase 3 trials for this vaccine candidate.”

Researchers did not find a correlation between preterm births in the treatment vs control groups with gestational age at the time of vaccination or with particular vaccine clinical trial material lots, race, ethnicity, maternal smoking, alcohol consumption, body mass index, or time between study vaccination and delivery, the GSK spokesperson said.

The spokesperson noted that the halted vaccine is different from GSK’s currently approved adjuvanted RSV vaccine (Arexvy) for adults aged 60 years or older.

What’s Next for Other Vaccines

Maternal vaccines have been effective in preventing other diseases in infants, such as tetanus, influenza, and pertussis, but RSV is a very hard virus to make a vaccine for, Dr. Glatt shared.

The need is great to have more than one option for a maternal RSV vaccine, he added, to address any potential supply concerns.

“People have to realize how serious RSV can be in infants,” he said. “It can be a fatal disease. This can be a serious illness even in healthy children.”

A version of this article appeared on Medscape.com.

TOPLINE:

A study found that 94% of best-selling baby cleansers contain allergens, despite their hypoallergenic claims.

METHODOLOGY:

• Many baby cleansers are marketed as “hypoallergenic,” but these claims are not validated. 
• This study assessed the potential allergens and marketing claims in best-selling baby cleansers. 
• The researchers collected ingredients and marketing claims of the top 50 best-selling baby body wash products sold on Amazon on April 4, 2023. 
• Ingredient lists were checked for potential allergens using the 2020 American Contact Dermatitis Society (ACDS) core allergen series, which lists 90 common allergens for adults and children.

TAKEAWAY:

• In the 50 cleansers tested, 10 allergens were identified. Overall, 94% of the cleansers contained at least one allergen, averaging 2.9 allergens per product; cocamidopropyl betaine  (72%), fragrance (64%), and sodium benzoate (54%) were the most common allergens. 
• All cleansers had at least five marketing claims, with an average of 10.9 claims per product; the most common claims were “paraben-free” (88%), “phthalate-free” (84%), “tear-free” (74%), and “hypoallergenic” or “allergy-tested” (74%). 
• There was no significant difference in the number of allergens in the cleansers marketed as “hypoallergenic” or “allergy tested” compared with cleansers that did not have these claims (P = .843).
• Fewer allergens were found in cleansers endorsed by the National Eczema Association (P = .004) or labeled “synthetic fragrance-free” (P = .003).
• There was a positive correlation between a greater number of allergens and an increased number of marketing claims (r = 0.547, P < .001) and a negative correlation between cost and number of allergens (r = −0.450, P = .001).

IN PRACTICE:

Because marketing claims like “hypoallergenic” may be misleading, “clinicians should counsel parents to carefully examine cleanser ingredients or consider selecting cleansers” endorsed by the National Eczema Association or another international eczema organization, especially for infants and children with a history of atopic dermatitis, the authors wrote. 

SOURCE:

The study, led by Sasan D. Noveir, BA, from the University of California, Los Angeles, and coauthors from the division of dermatology at UCLA, was published online in Pediatric Dermatology.

LIMITATIONS:

The study only evaluated top-selling products from a single online source at a specific time, which may limit generalizability. Potential allergens not included in the ACDS core series may be present.

DISCLOSURES:

The study did not disclose any funding source. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A study found that 94% of best-selling baby cleansers contain allergens, despite their hypoallergenic claims.

METHODOLOGY:

• Many baby cleansers are marketed as “hypoallergenic,” but these claims are not validated. 
• This study assessed the potential allergens and marketing claims in best-selling baby cleansers. 
• The researchers collected ingredients and marketing claims of the top 50 best-selling baby body wash products sold on Amazon on April 4, 2023. 
• Ingredient lists were checked for potential allergens using the 2020 American Contact Dermatitis Society (ACDS) core allergen series, which lists 90 common allergens for adults and children.

TAKEAWAY:

• In the 50 cleansers tested, 10 allergens were identified. Overall, 94% of the cleansers contained at least one allergen, averaging 2.9 allergens per product; cocamidopropyl betaine  (72%), fragrance (64%), and sodium benzoate (54%) were the most common allergens. 
• All cleansers had at least five marketing claims, with an average of 10.9 claims per product; the most common claims were “paraben-free” (88%), “phthalate-free” (84%), “tear-free” (74%), and “hypoallergenic” or “allergy-tested” (74%). 
• There was no significant difference in the number of allergens in the cleansers marketed as “hypoallergenic” or “allergy tested” compared with cleansers that did not have these claims (P = .843).
• Fewer allergens were found in cleansers endorsed by the National Eczema Association (P = .004) or labeled “synthetic fragrance-free” (P = .003).
• There was a positive correlation between a greater number of allergens and an increased number of marketing claims (r = 0.547, P < .001) and a negative correlation between cost and number of allergens (r = −0.450, P = .001).

IN PRACTICE:

Because marketing claims like “hypoallergenic” may be misleading, “clinicians should counsel parents to carefully examine cleanser ingredients or consider selecting cleansers” endorsed by the National Eczema Association or another international eczema organization, especially for infants and children with a history of atopic dermatitis, the authors wrote. 

SOURCE:

The study, led by Sasan D. Noveir, BA, from the University of California, Los Angeles, and coauthors from the division of dermatology at UCLA, was published online in Pediatric Dermatology.

LIMITATIONS:

The study only evaluated top-selling products from a single online source at a specific time, which may limit generalizability. Potential allergens not included in the ACDS core series may be present.

DISCLOSURES:

The study did not disclose any funding source. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A study found that 94% of best-selling baby cleansers contain allergens, despite their hypoallergenic claims.

METHODOLOGY:

• Many baby cleansers are marketed as “hypoallergenic,” but these claims are not validated. 
• This study assessed the potential allergens and marketing claims in best-selling baby cleansers. 
• The researchers collected ingredients and marketing claims of the top 50 best-selling baby body wash products sold on Amazon on April 4, 2023. 
• Ingredient lists were checked for potential allergens using the 2020 American Contact Dermatitis Society (ACDS) core allergen series, which lists 90 common allergens for adults and children.

TAKEAWAY:

• In the 50 cleansers tested, 10 allergens were identified. Overall, 94% of the cleansers contained at least one allergen, averaging 2.9 allergens per product; cocamidopropyl betaine  (72%), fragrance (64%), and sodium benzoate (54%) were the most common allergens. 
• All cleansers had at least five marketing claims, with an average of 10.9 claims per product; the most common claims were “paraben-free” (88%), “phthalate-free” (84%), “tear-free” (74%), and “hypoallergenic” or “allergy-tested” (74%). 
• There was no significant difference in the number of allergens in the cleansers marketed as “hypoallergenic” or “allergy tested” compared with cleansers that did not have these claims (P = .843).
• Fewer allergens were found in cleansers endorsed by the National Eczema Association (P = .004) or labeled “synthetic fragrance-free” (P = .003).
• There was a positive correlation between a greater number of allergens and an increased number of marketing claims (r = 0.547, P < .001) and a negative correlation between cost and number of allergens (r = −0.450, P = .001).

IN PRACTICE:

Because marketing claims like “hypoallergenic” may be misleading, “clinicians should counsel parents to carefully examine cleanser ingredients or consider selecting cleansers” endorsed by the National Eczema Association or another international eczema organization, especially for infants and children with a history of atopic dermatitis, the authors wrote. 

SOURCE:

The study, led by Sasan D. Noveir, BA, from the University of California, Los Angeles, and coauthors from the division of dermatology at UCLA, was published online in Pediatric Dermatology.

LIMITATIONS:

The study only evaluated top-selling products from a single online source at a specific time, which may limit generalizability. Potential allergens not included in the ACDS core series may be present.

DISCLOSURES:

The study did not disclose any funding source. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

The accuracy of information on TikTok videos about infantile hemangiomas (IHs) varies widely, researchers found.

METHODOLOGY:

• New parents may turn to TikTok for information about IHs, but little is known about the quality of videos on the social media platform related to the topic.
• Using the search term “hemangioma,” researchers reviewed the top 50 English-language TikTok videos that resulted from the query in November 2022.
• The researchers analyzed the videos for their content source, accuracy, and purpose and used Infantile Hemangioma Referral Score criteria to determine if the lesions pictured on the videos met criteria for referral to a specialist or not.

TAKEAWAY:

• Combined, the 50 videos were viewed 25.1 million times, had 2.6 million likes, and received 17,600 comments.
• Only 36 were considered likely to be IH. Of those 36 videos, the researchers deemed 33 (92%) to be potentially problematic, meriting referral to a specialist. The remaining three lesions could not be classified because of insufficient information.
• Of the 50 videos, 45 were created by individuals personally affected by IH (parents of a child with IH or young adults living with residual impacts), and only three were created by physicians (two by plastic surgeons and one by a neonatologist).
• In terms of content, 2 of the 45 videos created by someone personally affected by IH contained inaccurate information, while all three of videos created by physicians contained inaccurate information, such as oversimplification of the prognosis or incorrect nomenclature.

IN PRACTICE:

“Providers should be aware that TikTok may be useful for promoting birthmark awareness, but that it should not be relied on for accurate information about IHs,” the authors wrote.

SOURCE:

First author Sonora Yun, a medical student at Columbia University College of Physicians and Surgeons, New York City, conducted the research with Maria C. Garzon, MD, and Kimberly D. Morel, MD, who are board-certified pediatric dermatologists at Columbia. The study was published in Pediatric Dermatology.

LIMITATIONS:

The authors noted no specific limitations to the study.

DISCLOSURES:

The researchers reported having no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

The accuracy of information on TikTok videos about infantile hemangiomas (IHs) varies widely, researchers found.

METHODOLOGY:

• New parents may turn to TikTok for information about IHs, but little is known about the quality of videos on the social media platform related to the topic.
• Using the search term “hemangioma,” researchers reviewed the top 50 English-language TikTok videos that resulted from the query in November 2022.
• The researchers analyzed the videos for their content source, accuracy, and purpose and used Infantile Hemangioma Referral Score criteria to determine if the lesions pictured on the videos met criteria for referral to a specialist or not.

TAKEAWAY:

• Combined, the 50 videos were viewed 25.1 million times, had 2.6 million likes, and received 17,600 comments.
• Only 36 were considered likely to be IH. Of those 36 videos, the researchers deemed 33 (92%) to be potentially problematic, meriting referral to a specialist. The remaining three lesions could not be classified because of insufficient information.
• Of the 50 videos, 45 were created by individuals personally affected by IH (parents of a child with IH or young adults living with residual impacts), and only three were created by physicians (two by plastic surgeons and one by a neonatologist).
• In terms of content, 2 of the 45 videos created by someone personally affected by IH contained inaccurate information, while all three of videos created by physicians contained inaccurate information, such as oversimplification of the prognosis or incorrect nomenclature.

IN PRACTICE:

“Providers should be aware that TikTok may be useful for promoting birthmark awareness, but that it should not be relied on for accurate information about IHs,” the authors wrote.

SOURCE:

First author Sonora Yun, a medical student at Columbia University College of Physicians and Surgeons, New York City, conducted the research with Maria C. Garzon, MD, and Kimberly D. Morel, MD, who are board-certified pediatric dermatologists at Columbia. The study was published in Pediatric Dermatology.

LIMITATIONS:

The authors noted no specific limitations to the study.

DISCLOSURES:

The researchers reported having no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

The accuracy of information on TikTok videos about infantile hemangiomas (IHs) varies widely, researchers found.

METHODOLOGY:

• New parents may turn to TikTok for information about IHs, but little is known about the quality of videos on the social media platform related to the topic.
• Using the search term “hemangioma,” researchers reviewed the top 50 English-language TikTok videos that resulted from the query in November 2022.
• The researchers analyzed the videos for their content source, accuracy, and purpose and used Infantile Hemangioma Referral Score criteria to determine if the lesions pictured on the videos met criteria for referral to a specialist or not.

TAKEAWAY:

• Combined, the 50 videos were viewed 25.1 million times, had 2.6 million likes, and received 17,600 comments.
• Only 36 were considered likely to be IH. Of those 36 videos, the researchers deemed 33 (92%) to be potentially problematic, meriting referral to a specialist. The remaining three lesions could not be classified because of insufficient information.
• Of the 50 videos, 45 were created by individuals personally affected by IH (parents of a child with IH or young adults living with residual impacts), and only three were created by physicians (two by plastic surgeons and one by a neonatologist).
• In terms of content, 2 of the 45 videos created by someone personally affected by IH contained inaccurate information, while all three of videos created by physicians contained inaccurate information, such as oversimplification of the prognosis or incorrect nomenclature.

IN PRACTICE:

“Providers should be aware that TikTok may be useful for promoting birthmark awareness, but that it should not be relied on for accurate information about IHs,” the authors wrote.

SOURCE:

First author Sonora Yun, a medical student at Columbia University College of Physicians and Surgeons, New York City, conducted the research with Maria C. Garzon, MD, and Kimberly D. Morel, MD, who are board-certified pediatric dermatologists at Columbia. The study was published in Pediatric Dermatology.

LIMITATIONS:

The authors noted no specific limitations to the study.

DISCLOSURES:

The researchers reported having no disclosures.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) announced the removal of the endocrine-disrupting chemicals (EDCs) per- and polyfluoroalkyl substances (PFAS) from food packaging.

Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.

In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.

PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
 

Endocrine Society Report Sounds the Alarm About PFAS and Others

The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.

“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.

The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.

At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”

Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”

While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.

Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.

Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.

“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
 

New Data on Four Classes of EDCs

Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.

The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.

Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.

Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.

The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
 

‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’

Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.

The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”

The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) announced the removal of the endocrine-disrupting chemicals (EDCs) per- and polyfluoroalkyl substances (PFAS) from food packaging.

Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.

In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.

PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
 

Endocrine Society Report Sounds the Alarm About PFAS and Others

The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.

“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.

The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.

At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”

Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”

While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.

Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.

Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.

“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
 

New Data on Four Classes of EDCs

Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.

The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.

Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.

Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.

The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
 

‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’

Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.

The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”

The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) announced the removal of the endocrine-disrupting chemicals (EDCs) per- and polyfluoroalkyl substances (PFAS) from food packaging.

Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.

In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.

PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
 

Endocrine Society Report Sounds the Alarm About PFAS and Others

The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.

“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.

The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.

At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”

Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”

While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.

Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.

Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.

“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
 

New Data on Four Classes of EDCs

Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.

The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.

Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.

Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.

The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
 

‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’

Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.

The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”

The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.

A version of this article appeared on Medscape.com.

TOPLINE:

A national study in Israel demonstrates the feasibility and diagnostic benefits of rapid trio genome sequencing in critically ill neonates.

METHODOLOGY:

• Researchers conducted a prospective, multicenter cohort study from October 2021 to December 2022, involving all Israeli medical genetics institutes and neonatal intensive care units.
• A total of 130 critically ill neonates suspected of having a genetic disorder were enrolled, with rapid genome sequencing results expected within 10 days.

TAKEAWAY:

• Rapid trio genome sequencing diagnosed 50% of the neonates with disease-causing variants, including 12 chromosomal and 52 monogenic conditions.
• Another 11% had variants of unknown significance that were suspected to be disease-causing, and 1% had a novel gene suspected of causing disease.
• The mean turnaround time for the rapid reports was 7 days, demonstrating the feasibility of implementing rapid genome sequencing in a national healthcare setting, the researchers said.
• Genomic testing led to a change in clinical management for 22% of the neonates, which shows the clinical utility of this approach to diagnosis, they said.

IN PRACTICE:

Genetic testing may identify patients who are candidates for precision medical treatment and inform family planning, which is “critical for families with a severely affected or deceased child,” the study authors wrote.

SOURCE:

The corresponding author for the study was Daphna Marom, MD, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. It was published online on February 22, 2024, in JAMA Network Open.

LIMITATIONS:

The study’s reliance on voluntary participation may have introduced referral bias, potentially affecting the diagnostic rates. The long-term impact of diagnosis on survival, growth, and development remains to be evaluated. Bioinformatics tools have limitations, as shown by the missed detection of maternal uniparental disomy in one case of a hypotonic infant with Prader-Willi syndrome, the researchers noted. Clinical judgment is still essential, they said.

DISCLOSURES:

The study was sponsored by a collaboration between the Israeli Ministry of Health, Illumina, and the Genomics Center at the Tel Aviv Sourasky Medical Center. Illumina provided reagents, bioinformatics tools, and editorial assistance. Study authors disclosed financial ties to Illumina.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

A national study in Israel demonstrates the feasibility and diagnostic benefits of rapid trio genome sequencing in critically ill neonates.

METHODOLOGY:

• Researchers conducted a prospective, multicenter cohort study from October 2021 to December 2022, involving all Israeli medical genetics institutes and neonatal intensive care units.
• A total of 130 critically ill neonates suspected of having a genetic disorder were enrolled, with rapid genome sequencing results expected within 10 days.

TAKEAWAY:

• Rapid trio genome sequencing diagnosed 50% of the neonates with disease-causing variants, including 12 chromosomal and 52 monogenic conditions.
• Another 11% had variants of unknown significance that were suspected to be disease-causing, and 1% had a novel gene suspected of causing disease.
• The mean turnaround time for the rapid reports was 7 days, demonstrating the feasibility of implementing rapid genome sequencing in a national healthcare setting, the researchers said.
• Genomic testing led to a change in clinical management for 22% of the neonates, which shows the clinical utility of this approach to diagnosis, they said.

IN PRACTICE:

Genetic testing may identify patients who are candidates for precision medical treatment and inform family planning, which is “critical for families with a severely affected or deceased child,” the study authors wrote.

SOURCE:

The corresponding author for the study was Daphna Marom, MD, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. It was published online on February 22, 2024, in JAMA Network Open.

LIMITATIONS:

The study’s reliance on voluntary participation may have introduced referral bias, potentially affecting the diagnostic rates. The long-term impact of diagnosis on survival, growth, and development remains to be evaluated. Bioinformatics tools have limitations, as shown by the missed detection of maternal uniparental disomy in one case of a hypotonic infant with Prader-Willi syndrome, the researchers noted. Clinical judgment is still essential, they said.

DISCLOSURES:

The study was sponsored by a collaboration between the Israeli Ministry of Health, Illumina, and the Genomics Center at the Tel Aviv Sourasky Medical Center. Illumina provided reagents, bioinformatics tools, and editorial assistance. Study authors disclosed financial ties to Illumina.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

A national study in Israel demonstrates the feasibility and diagnostic benefits of rapid trio genome sequencing in critically ill neonates.

METHODOLOGY:

• Researchers conducted a prospective, multicenter cohort study from October 2021 to December 2022, involving all Israeli medical genetics institutes and neonatal intensive care units.
• A total of 130 critically ill neonates suspected of having a genetic disorder were enrolled, with rapid genome sequencing results expected within 10 days.

TAKEAWAY:

• Rapid trio genome sequencing diagnosed 50% of the neonates with disease-causing variants, including 12 chromosomal and 52 monogenic conditions.
• Another 11% had variants of unknown significance that were suspected to be disease-causing, and 1% had a novel gene suspected of causing disease.
• The mean turnaround time for the rapid reports was 7 days, demonstrating the feasibility of implementing rapid genome sequencing in a national healthcare setting, the researchers said.
• Genomic testing led to a change in clinical management for 22% of the neonates, which shows the clinical utility of this approach to diagnosis, they said.

IN PRACTICE:

Genetic testing may identify patients who are candidates for precision medical treatment and inform family planning, which is “critical for families with a severely affected or deceased child,” the study authors wrote.

SOURCE:

The corresponding author for the study was Daphna Marom, MD, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. It was published online on February 22, 2024, in JAMA Network Open.

LIMITATIONS:

The study’s reliance on voluntary participation may have introduced referral bias, potentially affecting the diagnostic rates. The long-term impact of diagnosis on survival, growth, and development remains to be evaluated. Bioinformatics tools have limitations, as shown by the missed detection of maternal uniparental disomy in one case of a hypotonic infant with Prader-Willi syndrome, the researchers noted. Clinical judgment is still essential, they said.

DISCLOSURES:

The study was sponsored by a collaboration between the Israeli Ministry of Health, Illumina, and the Genomics Center at the Tel Aviv Sourasky Medical Center. Illumina provided reagents, bioinformatics tools, and editorial assistance. Study authors disclosed financial ties to Illumina.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

Three out of five sudden unexpected infant deaths (SUID) happen when the baby is sharing a sleep space with at least one other infant, child, or adult, according to new data published online in Pediatrics.

SUID occur in infants less than 1 year old. The deaths happen without an obvious cause before investigation and account for 3,400 deaths per year in the United States.

Alexa B. Erck Lambert, MPH, Maternal and Infant Health Branch of the Centers for Disease Control and Prevention (CDC), led the study that examined 7,595 such deaths in 23 US jurisdictions from 2011 to 2020, using data from the CDC’s SUID Case Registry.

The researchers reported that the prevalence of surface sharing ranges from 34% to 64% among living infants and about 50% among SUID.
 

Common Factors

They found common factors when infants share sleep space compared with infants who did not. Those who shared space, for example, were often 0-3 months old; publicly insured; non-Hispanic Black; found in an adult bed, couch, or chair; exposed to maternal cigarette smoking prenatally; and supervised by a parent when they died or had a supervisor who was impaired by drugs or alcohol at the time of death.

Having a supervisor who was impaired by drugs or alcohol was much more common among sharing (16.3%) than nonsharing infants (4.7%).

The American Academy of Pediatrics (AAP) guidance says a safe sleep environment for infants includes a place to sleep on a nonshared sleep surface (in a crib or bassinet) without soft bedding, and lying on the back facing up.
 

Most Who Died had Multiple Unsafe Sleep Factors

At least 76% of all SUID had multiple unsafe sleep factors present, regardless of whether the infants shared sleep space. Unsafe sleep factors include an inclined or soft sleep surface, sleeping on the side or stomach, sleeping with soft or loose bedding or objects, not breastfeeding, prenatal or environmental exposure to cigarette smoke, and overheating.

Sharing sleep space combined with parents’ smoking and maternal alcohol or drug use greatly increases risk of sudden infant death, the authors noted.
 

Sharing More Common With Multiples

Among SUID, surface sharing was more common among multiples than singletons and more common in an adult bed than in the same crib. The authors noted that parents often cite financial reasons for such arrangements.

However, AAP recommends multiples sleep on separate surfaces. The authors say pediatricians and other healthcare providers should be aware of free crib distribution programs. A study by Hauck et al. found “crib distribution and safe sleep education positively influence knowledge and practices about safe sleep.”

Robin Haynes, PhD, who studies causes underlying the pathology of SIDS at Boston Children’s Hospital, pointed to the Cribs for Kids website as a place for parents and clinicians to start for help with providing separate sleeping surfaces.

Dr. Haynes said the large number of infants included is a strength of the study. The findings help confirm the risk of sharing a sleep surface, she said, but the details on characteristics of sleep-sharing environments provide “novel insight into this problem,” she said.

“For basic researchers,” Dr. Haynes said, “it reiterates that most cases of sudden and unexpected infant deaths are exposed to multiple risk factors. It also highlights the role that young infant age and maternal smoking have as risk factors that contribute to biological vulnerabilities in infants.”

The results also give clinicians more information on characteristics of bedsharing families and some of the factors related to bedsharing, including socioeconomic and behavioral factors, she said. She highlighted the higher risk of SUID when drug or alcohol impairment is involved while bedsharing.

“All of this information is really important and helps clinicians shape the safe sleep messages to families,” she said.

The study authors and Dr. Haynes report no relevant financial relationships.

Three out of five sudden unexpected infant deaths (SUID) happen when the baby is sharing a sleep space with at least one other infant, child, or adult, according to new data published online in Pediatrics.

SUID occur in infants less than 1 year old. The deaths happen without an obvious cause before investigation and account for 3,400 deaths per year in the United States.

Alexa B. Erck Lambert, MPH, Maternal and Infant Health Branch of the Centers for Disease Control and Prevention (CDC), led the study that examined 7,595 such deaths in 23 US jurisdictions from 2011 to 2020, using data from the CDC’s SUID Case Registry.

The researchers reported that the prevalence of surface sharing ranges from 34% to 64% among living infants and about 50% among SUID.
 

Common Factors

They found common factors when infants share sleep space compared with infants who did not. Those who shared space, for example, were often 0-3 months old; publicly insured; non-Hispanic Black; found in an adult bed, couch, or chair; exposed to maternal cigarette smoking prenatally; and supervised by a parent when they died or had a supervisor who was impaired by drugs or alcohol at the time of death.

Having a supervisor who was impaired by drugs or alcohol was much more common among sharing (16.3%) than nonsharing infants (4.7%).

The American Academy of Pediatrics (AAP) guidance says a safe sleep environment for infants includes a place to sleep on a nonshared sleep surface (in a crib or bassinet) without soft bedding, and lying on the back facing up.
 

Most Who Died had Multiple Unsafe Sleep Factors

At least 76% of all SUID had multiple unsafe sleep factors present, regardless of whether the infants shared sleep space. Unsafe sleep factors include an inclined or soft sleep surface, sleeping on the side or stomach, sleeping with soft or loose bedding or objects, not breastfeeding, prenatal or environmental exposure to cigarette smoke, and overheating.

Sharing sleep space combined with parents’ smoking and maternal alcohol or drug use greatly increases risk of sudden infant death, the authors noted.
 

Sharing More Common With Multiples

Among SUID, surface sharing was more common among multiples than singletons and more common in an adult bed than in the same crib. The authors noted that parents often cite financial reasons for such arrangements.

However, AAP recommends multiples sleep on separate surfaces. The authors say pediatricians and other healthcare providers should be aware of free crib distribution programs. A study by Hauck et al. found “crib distribution and safe sleep education positively influence knowledge and practices about safe sleep.”

Robin Haynes, PhD, who studies causes underlying the pathology of SIDS at Boston Children’s Hospital, pointed to the Cribs for Kids website as a place for parents and clinicians to start for help with providing separate sleeping surfaces.

Dr. Haynes said the large number of infants included is a strength of the study. The findings help confirm the risk of sharing a sleep surface, she said, but the details on characteristics of sleep-sharing environments provide “novel insight into this problem,” she said.

“For basic researchers,” Dr. Haynes said, “it reiterates that most cases of sudden and unexpected infant deaths are exposed to multiple risk factors. It also highlights the role that young infant age and maternal smoking have as risk factors that contribute to biological vulnerabilities in infants.”

The results also give clinicians more information on characteristics of bedsharing families and some of the factors related to bedsharing, including socioeconomic and behavioral factors, she said. She highlighted the higher risk of SUID when drug or alcohol impairment is involved while bedsharing.

“All of this information is really important and helps clinicians shape the safe sleep messages to families,” she said.

The study authors and Dr. Haynes report no relevant financial relationships.

Three out of five sudden unexpected infant deaths (SUID) happen when the baby is sharing a sleep space with at least one other infant, child, or adult, according to new data published online in Pediatrics.

SUID occur in infants less than 1 year old. The deaths happen without an obvious cause before investigation and account for 3,400 deaths per year in the United States.

Alexa B. Erck Lambert, MPH, Maternal and Infant Health Branch of the Centers for Disease Control and Prevention (CDC), led the study that examined 7,595 such deaths in 23 US jurisdictions from 2011 to 2020, using data from the CDC’s SUID Case Registry.

The researchers reported that the prevalence of surface sharing ranges from 34% to 64% among living infants and about 50% among SUID.
 

Common Factors

They found common factors when infants share sleep space compared with infants who did not. Those who shared space, for example, were often 0-3 months old; publicly insured; non-Hispanic Black; found in an adult bed, couch, or chair; exposed to maternal cigarette smoking prenatally; and supervised by a parent when they died or had a supervisor who was impaired by drugs or alcohol at the time of death.

Having a supervisor who was impaired by drugs or alcohol was much more common among sharing (16.3%) than nonsharing infants (4.7%).

The American Academy of Pediatrics (AAP) guidance says a safe sleep environment for infants includes a place to sleep on a nonshared sleep surface (in a crib or bassinet) without soft bedding, and lying on the back facing up.
 

Most Who Died had Multiple Unsafe Sleep Factors

At least 76% of all SUID had multiple unsafe sleep factors present, regardless of whether the infants shared sleep space. Unsafe sleep factors include an inclined or soft sleep surface, sleeping on the side or stomach, sleeping with soft or loose bedding or objects, not breastfeeding, prenatal or environmental exposure to cigarette smoke, and overheating.

Sharing sleep space combined with parents’ smoking and maternal alcohol or drug use greatly increases risk of sudden infant death, the authors noted.
 

Sharing More Common With Multiples

Among SUID, surface sharing was more common among multiples than singletons and more common in an adult bed than in the same crib. The authors noted that parents often cite financial reasons for such arrangements.

However, AAP recommends multiples sleep on separate surfaces. The authors say pediatricians and other healthcare providers should be aware of free crib distribution programs. A study by Hauck et al. found “crib distribution and safe sleep education positively influence knowledge and practices about safe sleep.”

Robin Haynes, PhD, who studies causes underlying the pathology of SIDS at Boston Children’s Hospital, pointed to the Cribs for Kids website as a place for parents and clinicians to start for help with providing separate sleeping surfaces.

Dr. Haynes said the large number of infants included is a strength of the study. The findings help confirm the risk of sharing a sleep surface, she said, but the details on characteristics of sleep-sharing environments provide “novel insight into this problem,” she said.

“For basic researchers,” Dr. Haynes said, “it reiterates that most cases of sudden and unexpected infant deaths are exposed to multiple risk factors. It also highlights the role that young infant age and maternal smoking have as risk factors that contribute to biological vulnerabilities in infants.”

The results also give clinicians more information on characteristics of bedsharing families and some of the factors related to bedsharing, including socioeconomic and behavioral factors, she said. She highlighted the higher risk of SUID when drug or alcohol impairment is involved while bedsharing.

“All of this information is really important and helps clinicians shape the safe sleep messages to families,” she said.

The study authors and Dr. Haynes report no relevant financial relationships.

TOPLINE:

Tinea capitis management varies among US-based pediatric dermatologists, a national survey found.

METHODOLOGY:

• The fungal scalp infection tinea capitis affects an estimated 3%-13% of children.
• While international guidelines exist for the treatment of tinea capitis in infants and children, no such document has been developed in the United States.
• Researchers distributed a survey by email to dermatologists through the  and the Society for Pediatric Dermatology in the United States, asking about how they treated and managed pediatric patients with tinea capitis; 56 dermatologists participated.

TAKEAWAY:

• Most respondents (88.2%) said they felt comfortable prescribing oral medications prior to confirmation for those aged 2-18 years ( was the most common choice in 60.4% of cases), compared with 81.6% for those aged 2 months to 2 years ( was the most common treatment choice in 41.5% of cases), and 48.7% for those aged 0-2 months ( was the most common choice in 28.6% of cases).
• When asked what topical medication they would start prior to confirmation, most respondents said  shampoo (62.3% for those aged 0-2 months and 75.5% each for those aged 2 months to 2 years and those aged 2-18 years), yet between 11.3% and 13% said they would use none.
• The most common form of confirmatory testing was , followed by potassium hydroxide preparation, trichoscopy, and Wood’s lamp.
• More than half of survey respondents would alter their choice of oral medication based on culture results, but most would not change their topical medication preference.

IN PRACTICE:

“The management of tinea capitis in the United States is currently variable, particularly with the introduction of newer antifungals,” the authors wrote. “Future steps involve establishing evidence-based clinical practice guidelines that consider drug efficacy, safety profiles, and costs.”

SOURCE:

Bernard Cohen, MD, of the Departments of Pediatrics and Dermatology at Johns Hopkins University, Baltimore, Maryland, led the research, which was published in Pediatric Dermatology.

LIMITATIONS:

Lower response rates associated with online surveys and predefined age groups restrict the granularity of responses.

DISCLOSURES:

The authors reported having no financial disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Tinea capitis management varies among US-based pediatric dermatologists, a national survey found.

METHODOLOGY:

• The fungal scalp infection tinea capitis affects an estimated 3%-13% of children.
• While international guidelines exist for the treatment of tinea capitis in infants and children, no such document has been developed in the United States.
• Researchers distributed a survey by email to dermatologists through the  and the Society for Pediatric Dermatology in the United States, asking about how they treated and managed pediatric patients with tinea capitis; 56 dermatologists participated.

TAKEAWAY:

• Most respondents (88.2%) said they felt comfortable prescribing oral medications prior to confirmation for those aged 2-18 years ( was the most common choice in 60.4% of cases), compared with 81.6% for those aged 2 months to 2 years ( was the most common treatment choice in 41.5% of cases), and 48.7% for those aged 0-2 months ( was the most common choice in 28.6% of cases).
• When asked what topical medication they would start prior to confirmation, most respondents said  shampoo (62.3% for those aged 0-2 months and 75.5% each for those aged 2 months to 2 years and those aged 2-18 years), yet between 11.3% and 13% said they would use none.
• The most common form of confirmatory testing was , followed by potassium hydroxide preparation, trichoscopy, and Wood’s lamp.
• More than half of survey respondents would alter their choice of oral medication based on culture results, but most would not change their topical medication preference.

IN PRACTICE:

“The management of tinea capitis in the United States is currently variable, particularly with the introduction of newer antifungals,” the authors wrote. “Future steps involve establishing evidence-based clinical practice guidelines that consider drug efficacy, safety profiles, and costs.”

SOURCE:

Bernard Cohen, MD, of the Departments of Pediatrics and Dermatology at Johns Hopkins University, Baltimore, Maryland, led the research, which was published in Pediatric Dermatology.

LIMITATIONS:

Lower response rates associated with online surveys and predefined age groups restrict the granularity of responses.

DISCLOSURES:

The authors reported having no financial disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Tinea capitis management varies among US-based pediatric dermatologists, a national survey found.

METHODOLOGY:

• The fungal scalp infection tinea capitis affects an estimated 3%-13% of children.
• While international guidelines exist for the treatment of tinea capitis in infants and children, no such document has been developed in the United States.
• Researchers distributed a survey by email to dermatologists through the  and the Society for Pediatric Dermatology in the United States, asking about how they treated and managed pediatric patients with tinea capitis; 56 dermatologists participated.

TAKEAWAY:

• Most respondents (88.2%) said they felt comfortable prescribing oral medications prior to confirmation for those aged 2-18 years ( was the most common choice in 60.4% of cases), compared with 81.6% for those aged 2 months to 2 years ( was the most common treatment choice in 41.5% of cases), and 48.7% for those aged 0-2 months ( was the most common choice in 28.6% of cases).
• When asked what topical medication they would start prior to confirmation, most respondents said  shampoo (62.3% for those aged 0-2 months and 75.5% each for those aged 2 months to 2 years and those aged 2-18 years), yet between 11.3% and 13% said they would use none.
• The most common form of confirmatory testing was , followed by potassium hydroxide preparation, trichoscopy, and Wood’s lamp.
• More than half of survey respondents would alter their choice of oral medication based on culture results, but most would not change their topical medication preference.

IN PRACTICE:

“The management of tinea capitis in the United States is currently variable, particularly with the introduction of newer antifungals,” the authors wrote. “Future steps involve establishing evidence-based clinical practice guidelines that consider drug efficacy, safety profiles, and costs.”

SOURCE:

Bernard Cohen, MD, of the Departments of Pediatrics and Dermatology at Johns Hopkins University, Baltimore, Maryland, led the research, which was published in Pediatric Dermatology.

LIMITATIONS:

Lower response rates associated with online surveys and predefined age groups restrict the granularity of responses.

DISCLOSURES:

The authors reported having no financial disclosures.

A version of this article appeared on Medscape.com.

Many infants have experienced an episode of apnea, defined as a pause in respiration of 20 seconds or more. Most episodes remain unexplained, and no underlying cause can be found. Historically, these were referred to as “near-miss SIDS,” episodes, but that label suggested that all of these events would have ended in death had someone not intervened. New descriptive terminology was needed.

In the mid-1980s, the term “apparent life-threatening event” (ALTE) was adopted. But that term, too, was an overstatement, because although scary for parents, these brief apnea episodes were not, in most cases, truly life-threatening.

In 2013, authors of a systematic review coined the term “brief resolved unexplained event” (BRUE). This review also addressed the history and physical exam features associated with risk for a subsequent episode. It was felt that hospitalization and testing might be warranted if certain infants could be identified as high risk for recurrence.

What Is Considered a BRUE?

In the current working definition of BRUE, the child must be < 1 year old. The episode must be a sudden, brief, and resolved, with one or more of these characteristics:

• Cyanosis or pallor (but not turning red)
• A change in breathing (absent, decreased, or irregular)
• A change in tone (hypertonia or hypotonia)
• A change in responsiveness.

Furthermore, to qualify as a BRUE, no explanation can be found for the event based on the history and physical examination but before any laboratory testing is done. The definition also excludes children with known potential explanatory diagnoses (such as gastroesophageal reflux or bronchiolitis) and those who are otherwise symptomatically ill at the time of the event.
 

Decision to Admit and Recurrence Risk

An apnea event in an otherwise healthy infant, regardless of what it’s called, puts providers and parents in a difficult position. Should the infant be hospitalized for further monitoring and potentially more invasive testing to determine the cause of the episode? And what are the chances that the episode will be repeated?

A clinical practice guideline (CPG) for BRUE, widely adopted in 2016, resulted in significant reductions in healthcare utilization. The CPG attempted to identify low-risk infants who could safely be discharged from the emergency department. Although the CPG improved outcomes, experts acknowledged that an underlying problem was not likely to be identified even among infants deemed high risk, and these infants would be hospitalized unnecessarily.

Available data were simply insufficient to support this decision. So, with the goal of identifying factors that could help predict recurrent BRUE risk, a 15-hospital collaborative study was undertaken, followed by the development and validation of a clinical decision rule for predicting the risk for a serious underlying diagnosis or event recurrence among infants presenting with BRUE.

Here’s what we learned from more than 3000 cases of BRUE.

First, it turns out that it’s not easy to determine whether an infant is at low or high risk for recurrence of BRUE. Initially, 91.5% of patients enrolled in the study would have been labeled high risk.

Furthermore, a BRUE recurred in 14.3% of the cohort, and 4.8% of high-risk infants were found to have a serious undiagnosed condition. Seizures, airway anomalies, and gastroesophageal reflux were the top three causes of BRUE, but the spectrum of underlying pathology was quite considerable.

The problem was that 4.6% of the entire cohort were found to have a serious underlying condition, nearly identical to the proportion of high-risk infants with these conditions. This prompted the question of whether simply labeling infants “high risk” was really appropriate any longer. 
 

Revised BRUE Management

Although it hasn’t been possible to group infants neatly in low and high-risk categories, the data from that large cohort led to the development of the BRUE 2.0 criteria, which enabled more focused risk assessment of an infant who experienced a BRUE. With an app on MDCalc, these criteria allow providers to ascertain, and show families, a visual representation of their infant’s individualized risk for a subsequent BRUE and of having a serious underlying condition.

The cohort study also identified red flags from the history or physical exam of infants who experienced a BRUE: weight loss, failure to thrive, or a history of feeding problems. Exam findings such as a bulging fontanelle, forceful or bilious emesis, and evidence of gastrointestinal (GI) bleeding suggest a medical diagnosis rather than a BRUE. If GI-related causes are high on the differential, a feeding evaluation can be helpful. A feeding evaluation can be done in the outpatient setting and does not require hospitalization.

For suspicion of an underlying neurological condition (such as seizures), experts recommend obtaining a short EEG, which is highly sensitive for detecting infantile spasms and encephalopathy. They recommend reserving MRI for infants with abnormalities on EEG or physical exam. Metabolic or genetic testing should be done only if the infant looks ill, because most patients with genetic or inborn errors of metabolism will continue to have symptoms as they become older.

The approach to BRUE has moved into the realm of shared decision-making with families. The likelihood of identifying a serious diagnosis is low for most of these children. And unfortunately, no single test can diagnose the full spectrum of potential explanatory diagnoses. For example, data from 2023 demonstrate that only 1.1% of lab tests following a BRUE contributed to a diagnosis, and most of the time that was a positive viral test. Similarly, imaging was helpful in only 1.5% of cases. So, explaining the evidence and deciding along with parents what is reasonable to do (or not do) is the current state of affairs.
 

My Take

As I reflect back on two and a half decades of caring for these patients, I believe that recent data have helped us a great deal. We do less testing and admit fewer infants to the hospital than we did 20 years ago, and that’s a good thing. Nevertheless, looking for a few red flags, having a high index of suspicion when the clinical exam is abnormal, and engaging in shared decision-making with families can help make the caring for these challenging patients more bearable and lead to better outcomes for all involved.

Dr. Basco is Professor, Department of Pediatrics, Medical University of South Carolina (MUSC); Director, Division of General Pediatrics, Department of Pediatrics, MUSC Children’s Hospital, Charleston, South Carolina. He has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Many infants have experienced an episode of apnea, defined as a pause in respiration of 20 seconds or more. Most episodes remain unexplained, and no underlying cause can be found. Historically, these were referred to as “near-miss SIDS,” episodes, but that label suggested that all of these events would have ended in death had someone not intervened. New descriptive terminology was needed.

In the mid-1980s, the term “apparent life-threatening event” (ALTE) was adopted. But that term, too, was an overstatement, because although scary for parents, these brief apnea episodes were not, in most cases, truly life-threatening.

In 2013, authors of a systematic review coined the term “brief resolved unexplained event” (BRUE). This review also addressed the history and physical exam features associated with risk for a subsequent episode. It was felt that hospitalization and testing might be warranted if certain infants could be identified as high risk for recurrence.

What Is Considered a BRUE?

In the current working definition of BRUE, the child must be < 1 year old. The episode must be a sudden, brief, and resolved, with one or more of these characteristics:

• Cyanosis or pallor (but not turning red)
• A change in breathing (absent, decreased, or irregular)
• A change in tone (hypertonia or hypotonia)
• A change in responsiveness.

Furthermore, to qualify as a BRUE, no explanation can be found for the event based on the history and physical examination but before any laboratory testing is done. The definition also excludes children with known potential explanatory diagnoses (such as gastroesophageal reflux or bronchiolitis) and those who are otherwise symptomatically ill at the time of the event.
 

Decision to Admit and Recurrence Risk

An apnea event in an otherwise healthy infant, regardless of what it’s called, puts providers and parents in a difficult position. Should the infant be hospitalized for further monitoring and potentially more invasive testing to determine the cause of the episode? And what are the chances that the episode will be repeated?

A clinical practice guideline (CPG) for BRUE, widely adopted in 2016, resulted in significant reductions in healthcare utilization. The CPG attempted to identify low-risk infants who could safely be discharged from the emergency department. Although the CPG improved outcomes, experts acknowledged that an underlying problem was not likely to be identified even among infants deemed high risk, and these infants would be hospitalized unnecessarily.

Available data were simply insufficient to support this decision. So, with the goal of identifying factors that could help predict recurrent BRUE risk, a 15-hospital collaborative study was undertaken, followed by the development and validation of a clinical decision rule for predicting the risk for a serious underlying diagnosis or event recurrence among infants presenting with BRUE.

Here’s what we learned from more than 3000 cases of BRUE.

First, it turns out that it’s not easy to determine whether an infant is at low or high risk for recurrence of BRUE. Initially, 91.5% of patients enrolled in the study would have been labeled high risk.

Furthermore, a BRUE recurred in 14.3% of the cohort, and 4.8% of high-risk infants were found to have a serious undiagnosed condition. Seizures, airway anomalies, and gastroesophageal reflux were the top three causes of BRUE, but the spectrum of underlying pathology was quite considerable.

The problem was that 4.6% of the entire cohort were found to have a serious underlying condition, nearly identical to the proportion of high-risk infants with these conditions. This prompted the question of whether simply labeling infants “high risk” was really appropriate any longer. 
 

Revised BRUE Management

Although it hasn’t been possible to group infants neatly in low and high-risk categories, the data from that large cohort led to the development of the BRUE 2.0 criteria, which enabled more focused risk assessment of an infant who experienced a BRUE. With an app on MDCalc, these criteria allow providers to ascertain, and show families, a visual representation of their infant’s individualized risk for a subsequent BRUE and of having a serious underlying condition.

The cohort study also identified red flags from the history or physical exam of infants who experienced a BRUE: weight loss, failure to thrive, or a history of feeding problems. Exam findings such as a bulging fontanelle, forceful or bilious emesis, and evidence of gastrointestinal (GI) bleeding suggest a medical diagnosis rather than a BRUE. If GI-related causes are high on the differential, a feeding evaluation can be helpful. A feeding evaluation can be done in the outpatient setting and does not require hospitalization.

For suspicion of an underlying neurological condition (such as seizures), experts recommend obtaining a short EEG, which is highly sensitive for detecting infantile spasms and encephalopathy. They recommend reserving MRI for infants with abnormalities on EEG or physical exam. Metabolic or genetic testing should be done only if the infant looks ill, because most patients with genetic or inborn errors of metabolism will continue to have symptoms as they become older.

The approach to BRUE has moved into the realm of shared decision-making with families. The likelihood of identifying a serious diagnosis is low for most of these children. And unfortunately, no single test can diagnose the full spectrum of potential explanatory diagnoses. For example, data from 2023 demonstrate that only 1.1% of lab tests following a BRUE contributed to a diagnosis, and most of the time that was a positive viral test. Similarly, imaging was helpful in only 1.5% of cases. So, explaining the evidence and deciding along with parents what is reasonable to do (or not do) is the current state of affairs.
 

My Take

As I reflect back on two and a half decades of caring for these patients, I believe that recent data have helped us a great deal. We do less testing and admit fewer infants to the hospital than we did 20 years ago, and that’s a good thing. Nevertheless, looking for a few red flags, having a high index of suspicion when the clinical exam is abnormal, and engaging in shared decision-making with families can help make the caring for these challenging patients more bearable and lead to better outcomes for all involved.

Dr. Basco is Professor, Department of Pediatrics, Medical University of South Carolina (MUSC); Director, Division of General Pediatrics, Department of Pediatrics, MUSC Children’s Hospital, Charleston, South Carolina. He has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Many infants have experienced an episode of apnea, defined as a pause in respiration of 20 seconds or more. Most episodes remain unexplained, and no underlying cause can be found. Historically, these were referred to as “near-miss SIDS,” episodes, but that label suggested that all of these events would have ended in death had someone not intervened. New descriptive terminology was needed.

In the mid-1980s, the term “apparent life-threatening event” (ALTE) was adopted. But that term, too, was an overstatement, because although scary for parents, these brief apnea episodes were not, in most cases, truly life-threatening.

In 2013, authors of a systematic review coined the term “brief resolved unexplained event” (BRUE). This review also addressed the history and physical exam features associated with risk for a subsequent episode. It was felt that hospitalization and testing might be warranted if certain infants could be identified as high risk for recurrence.

What Is Considered a BRUE?

In the current working definition of BRUE, the child must be < 1 year old. The episode must be a sudden, brief, and resolved, with one or more of these characteristics:

• Cyanosis or pallor (but not turning red)
• A change in breathing (absent, decreased, or irregular)
• A change in tone (hypertonia or hypotonia)
• A change in responsiveness.

Furthermore, to qualify as a BRUE, no explanation can be found for the event based on the history and physical examination but before any laboratory testing is done. The definition also excludes children with known potential explanatory diagnoses (such as gastroesophageal reflux or bronchiolitis) and those who are otherwise symptomatically ill at the time of the event.
 

Decision to Admit and Recurrence Risk

An apnea event in an otherwise healthy infant, regardless of what it’s called, puts providers and parents in a difficult position. Should the infant be hospitalized for further monitoring and potentially more invasive testing to determine the cause of the episode? And what are the chances that the episode will be repeated?

A clinical practice guideline (CPG) for BRUE, widely adopted in 2016, resulted in significant reductions in healthcare utilization. The CPG attempted to identify low-risk infants who could safely be discharged from the emergency department. Although the CPG improved outcomes, experts acknowledged that an underlying problem was not likely to be identified even among infants deemed high risk, and these infants would be hospitalized unnecessarily.

Available data were simply insufficient to support this decision. So, with the goal of identifying factors that could help predict recurrent BRUE risk, a 15-hospital collaborative study was undertaken, followed by the development and validation of a clinical decision rule for predicting the risk for a serious underlying diagnosis or event recurrence among infants presenting with BRUE.

Here’s what we learned from more than 3000 cases of BRUE.

First, it turns out that it’s not easy to determine whether an infant is at low or high risk for recurrence of BRUE. Initially, 91.5% of patients enrolled in the study would have been labeled high risk.

Furthermore, a BRUE recurred in 14.3% of the cohort, and 4.8% of high-risk infants were found to have a serious undiagnosed condition. Seizures, airway anomalies, and gastroesophageal reflux were the top three causes of BRUE, but the spectrum of underlying pathology was quite considerable.

The problem was that 4.6% of the entire cohort were found to have a serious underlying condition, nearly identical to the proportion of high-risk infants with these conditions. This prompted the question of whether simply labeling infants “high risk” was really appropriate any longer. 
 

Revised BRUE Management

Although it hasn’t been possible to group infants neatly in low and high-risk categories, the data from that large cohort led to the development of the BRUE 2.0 criteria, which enabled more focused risk assessment of an infant who experienced a BRUE. With an app on MDCalc, these criteria allow providers to ascertain, and show families, a visual representation of their infant’s individualized risk for a subsequent BRUE and of having a serious underlying condition.

The cohort study also identified red flags from the history or physical exam of infants who experienced a BRUE: weight loss, failure to thrive, or a history of feeding problems. Exam findings such as a bulging fontanelle, forceful or bilious emesis, and evidence of gastrointestinal (GI) bleeding suggest a medical diagnosis rather than a BRUE. If GI-related causes are high on the differential, a feeding evaluation can be helpful. A feeding evaluation can be done in the outpatient setting and does not require hospitalization.

For suspicion of an underlying neurological condition (such as seizures), experts recommend obtaining a short EEG, which is highly sensitive for detecting infantile spasms and encephalopathy. They recommend reserving MRI for infants with abnormalities on EEG or physical exam. Metabolic or genetic testing should be done only if the infant looks ill, because most patients with genetic or inborn errors of metabolism will continue to have symptoms as they become older.

The approach to BRUE has moved into the realm of shared decision-making with families. The likelihood of identifying a serious diagnosis is low for most of these children. And unfortunately, no single test can diagnose the full spectrum of potential explanatory diagnoses. For example, data from 2023 demonstrate that only 1.1% of lab tests following a BRUE contributed to a diagnosis, and most of the time that was a positive viral test. Similarly, imaging was helpful in only 1.5% of cases. So, explaining the evidence and deciding along with parents what is reasonable to do (or not do) is the current state of affairs.
 

My Take

As I reflect back on two and a half decades of caring for these patients, I believe that recent data have helped us a great deal. We do less testing and admit fewer infants to the hospital than we did 20 years ago, and that’s a good thing. Nevertheless, looking for a few red flags, having a high index of suspicion when the clinical exam is abnormal, and engaging in shared decision-making with families can help make the caring for these challenging patients more bearable and lead to better outcomes for all involved.

Dr. Basco is Professor, Department of Pediatrics, Medical University of South Carolina (MUSC); Director, Division of General Pediatrics, Department of Pediatrics, MUSC Children’s Hospital, Charleston, South Carolina. He has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.