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Nilotinib approved to treat kids with CML in EU
The European Commission has approved nilotinib (Tasigna®) for the treatment of pediatric patients.
The drug is now approved to treat children age 2 and older with newly diagnosed, Philadelphia chromosome-positive (Ph+), chronic phase (CP) chronic myeloid leukemia (CML) or Ph+ CP-CML with resistance or intolerance to prior therapy, including imatinib.
Nilotinib is the only second-generation tyrosine kinase inhibitor currently approved in the European Union (EU) for the treatment of Ph+ CP-CML in children. The approval applies to all EU member states.
According to Novartis, the expanded indication for nilotinib is based on 2 prospective studies of the drug in children with Ph+ CP-CML, which were part of a formal “pediatric investigation plan” agreed upon with the European Medicines Agency.
The company said 69 patients received nilotinib in these studies. The patients ranged in age from 2 to 18. They had either newly diagnosed Ph+ CP-CML or Ph+ CP-CML with resistance or intolerance to prior therapy, including imatinib.
In the newly diagnosed patients, the major molecular response (MMR) rate was 60.0% (95% CI: 38.7, 78.9) at 12 cycles, with 15 patients achieving MMR.
In patients with resistance or intolerance to prior therapy, the MMR rate was 40.9% (95% CI: 26.3, 56.8) at 12 cycles, with 18 patients being in MMR.
In newly diagnosed patients, the cumulative MMR rate was 64.0% by cycle 12. In patients with resistance or intolerance to prior therapy, the cumulative MMR rate was 47.7% by cycle 12.
Adverse events were generally consistent with those observed in adults, with the exception of hyperbilirubinemia and transaminase elevation, which were reported at a higher frequency than in adults.
The rate of grade 3/4 hyperbilirubinemia was 13.0%, the rate of grade 3/4 AST elevation was 1.4%, and the rate of grade 3/4 ALT elevation was 8.7%.
There were no deaths on treatment or after treatment discontinuation. 
The European Commission has approved nilotinib (Tasigna®) for the treatment of pediatric patients.
The drug is now approved to treat children age 2 and older with newly diagnosed, Philadelphia chromosome-positive (Ph+), chronic phase (CP) chronic myeloid leukemia (CML) or Ph+ CP-CML with resistance or intolerance to prior therapy, including imatinib.
Nilotinib is the only second-generation tyrosine kinase inhibitor currently approved in the European Union (EU) for the treatment of Ph+ CP-CML in children. The approval applies to all EU member states.
According to Novartis, the expanded indication for nilotinib is based on 2 prospective studies of the drug in children with Ph+ CP-CML, which were part of a formal “pediatric investigation plan” agreed upon with the European Medicines Agency.
The company said 69 patients received nilotinib in these studies. The patients ranged in age from 2 to 18. They had either newly diagnosed Ph+ CP-CML or Ph+ CP-CML with resistance or intolerance to prior therapy, including imatinib.
In the newly diagnosed patients, the major molecular response (MMR) rate was 60.0% (95% CI: 38.7, 78.9) at 12 cycles, with 15 patients achieving MMR.
In patients with resistance or intolerance to prior therapy, the MMR rate was 40.9% (95% CI: 26.3, 56.8) at 12 cycles, with 18 patients being in MMR.
In newly diagnosed patients, the cumulative MMR rate was 64.0% by cycle 12. In patients with resistance or intolerance to prior therapy, the cumulative MMR rate was 47.7% by cycle 12.
Adverse events were generally consistent with those observed in adults, with the exception of hyperbilirubinemia and transaminase elevation, which were reported at a higher frequency than in adults.
The rate of grade 3/4 hyperbilirubinemia was 13.0%, the rate of grade 3/4 AST elevation was 1.4%, and the rate of grade 3/4 ALT elevation was 8.7%.
There were no deaths on treatment or after treatment discontinuation.
The European Commission has approved nilotinib (Tasigna®) for the treatment of pediatric patients.
The drug is now approved to treat children age 2 and older with newly diagnosed, Philadelphia chromosome-positive (Ph+), chronic phase (CP) chronic myeloid leukemia (CML) or Ph+ CP-CML with resistance or intolerance to prior therapy, including imatinib.
Nilotinib is the only second-generation tyrosine kinase inhibitor currently approved in the European Union (EU) for the treatment of Ph+ CP-CML in children. The approval applies to all EU member states.
According to Novartis, the expanded indication for nilotinib is based on 2 prospective studies of the drug in children with Ph+ CP-CML, which were part of a formal “pediatric investigation plan” agreed upon with the European Medicines Agency.
The company said 69 patients received nilotinib in these studies. The patients ranged in age from 2 to 18. They had either newly diagnosed Ph+ CP-CML or Ph+ CP-CML with resistance or intolerance to prior therapy, including imatinib.
In the newly diagnosed patients, the major molecular response (MMR) rate was 60.0% (95% CI: 38.7, 78.9) at 12 cycles, with 15 patients achieving MMR.
In patients with resistance or intolerance to prior therapy, the MMR rate was 40.9% (95% CI: 26.3, 56.8) at 12 cycles, with 18 patients being in MMR.
In newly diagnosed patients, the cumulative MMR rate was 64.0% by cycle 12. In patients with resistance or intolerance to prior therapy, the cumulative MMR rate was 47.7% by cycle 12.
Adverse events were generally consistent with those observed in adults, with the exception of hyperbilirubinemia and transaminase elevation, which were reported at a higher frequency than in adults.
The rate of grade 3/4 hyperbilirubinemia was 13.0%, the rate of grade 3/4 AST elevation was 1.4%, and the rate of grade 3/4 ALT elevation was 8.7%.
There were no deaths on treatment or after treatment discontinuation.
CD22-CAR therapy shows activity in rel/ref B-ALL
Researchers say they have reported the first results demonstrating clinical activity of a CD22-directed chimeric antigen receptor (CAR) T-cell therapy in B-cell acute lymphoblastic leukemia (B-ALL).
The team conducted a phase 1 study of the therapy in 21 children and adults with relapsed/refractory B-ALL.
Twelve patients achieved a complete response (CR) to the treatment, with 3 patients still in CR at last follow-up.
Sixteen patients developed cytokine release syndrome (CRS), all grade 1 or 2.
Crystal Mackall, MD, of Stanford University in California, and her colleagues reported these results in Nature Medicine.*
“This is the first time that we’ve seen response rates anything like we achieved when we were first testing the CD19 CAR T therapy,” Dr Mackall said.
“We were all a little worried that we wouldn’t find anything comparable, but this study gives hope to the idea that there may be another similar, very potent treatment.”
Patients
Dr Mackall and her colleagues studied the CD22-CAR T-cell therapy in 21 patients with relapsed/refractory B-ALL. They had a median age of 19 (range, 7 to 30).
All of the patients had received a hematopoietic stem cell transplant at least once, and 2 patients had 2 prior transplants each. Seventeen patients had received prior CD19-directed immunotherapy. Fifteen had received CD19-directed CAR T-cell therapy, and 2 had received blinatumomab.
Lymphoblasts were CD19− or CD19dim in 10 patients (9 who had received a CD19-CAR and 1 treated with blinatumomab).
The median CD22 site density was 2839 molecules per cell (range, 613 to 13,452).
Dosing and DLTs
Patients received the CD22-CAR T-cell therapy at 1 of 3 dose levels:
- 0.3 × 106 CD22-CAR T cells per kg body weight (n=6)
- 1 × 106 cells per kg (n=13)
- 3 × 106 cells per kg (n=2).
There was 1 dose-limiting toxicity (DLT) at the first dose level. It was grade 3, self-limited, noninfectious diarrhea that occurred during CRS and resolved with supportive care.
The other DLT occurred in a patient who received treatment at the third dose level. This patient had grade 4 hypoxia that was associated with rapid disease progression. The patient required brief intubation, and the hypoxia was resolved within 24 hours of starting steroid treatment.
Based on these results, the second dose level became the recommended phase 2 dose.
Other adverse events
The researchers said the primary toxicity was CRS, which occurred in 16 patients. Nine patients had grade 1 CRS, and 7 had grade 2.
There were no cases of irreversible neurotoxicity or seizure reported. Among the first 16 patients with complete assessments, there were cases of transient visual hallucinations (n=2), mild unresponsiveness (n=1), mild disorientation (n=1), and mild to moderate pain (n=2). However, these incidents resolved by day 28.
One patient died from gram-negative rod sepsis that developed after the resolution of CRS and neutrophil count recovery to >1000 cells/μL blood. The patient had a history of multi-organ failure due to sepsis.
Response
Twelve patients (57%) had a CR, and 9 of them were minimal residual disease negative.
One CR occurred at the lowest dose of therapy, 1 occurred at the highest dose, and the remaining 10 CRs occurred in patients who received dose level 2.
The researchers said there was no evidence to suggest that previous CD19-directed immunotherapy or diminished surface expression of CD19 impacted response to the CD22-CAR T-cell therapy.
Of the 9 patients who did not respond, 4 progressed and 5 had stable disease.
The researchers said 4 non-responders had “very high disease burden with rapid disease progression.” And 2 non-responders expressed diminished or partial CD22 on leukemic blasts at the time of enrollment.
The median duration of response was 6 months (range, 1.5 to 21+ months). Three patients are still in CR at 6, 9, and 21 months of follow-up.
“The take-home message is that we’ve found another CAR T-cell therapy that displays high-level activity in this phase 1 trial,” Dr Mackall said. “But the relapse rate was also high. So this forces the field to get even more sophisticated. How much of a target is needed for successful, long-lasting treatment? What happens if we target both CD19 and CD22 simultaneously?”
The researchers are already tackling the last question by testing a CAR T-cell therapy that recognizes both CD19 and CD22. They’ve confirmed this therapy can kill cancer cells in vitro and in vivo. Now, they’re testing it in a clinical trial that has opened at Stanford University and will open soon at the National Cancer Institute.
*This research was supported, in part, by the Intramural Research Program, National Cancer Institute and NIH Clinical Center, National Institutes of Health; by a Stand Up to Cancer–St. Baldrick’s Pediatric Dream Team translational research grant; and by a St. Baldrick’s Foundation Scholar Award.
Researchers say they have reported the first results demonstrating clinical activity of a CD22-directed chimeric antigen receptor (CAR) T-cell therapy in B-cell acute lymphoblastic leukemia (B-ALL).
The team conducted a phase 1 study of the therapy in 21 children and adults with relapsed/refractory B-ALL.
Twelve patients achieved a complete response (CR) to the treatment, with 3 patients still in CR at last follow-up.
Sixteen patients developed cytokine release syndrome (CRS), all grade 1 or 2.
Crystal Mackall, MD, of Stanford University in California, and her colleagues reported these results in Nature Medicine.*
“This is the first time that we’ve seen response rates anything like we achieved when we were first testing the CD19 CAR T therapy,” Dr Mackall said.
“We were all a little worried that we wouldn’t find anything comparable, but this study gives hope to the idea that there may be another similar, very potent treatment.”
Patients
Dr Mackall and her colleagues studied the CD22-CAR T-cell therapy in 21 patients with relapsed/refractory B-ALL. They had a median age of 19 (range, 7 to 30).
All of the patients had received a hematopoietic stem cell transplant at least once, and 2 patients had 2 prior transplants each. Seventeen patients had received prior CD19-directed immunotherapy. Fifteen had received CD19-directed CAR T-cell therapy, and 2 had received blinatumomab.
Lymphoblasts were CD19− or CD19dim in 10 patients (9 who had received a CD19-CAR and 1 treated with blinatumomab).
The median CD22 site density was 2839 molecules per cell (range, 613 to 13,452).
Dosing and DLTs
Patients received the CD22-CAR T-cell therapy at 1 of 3 dose levels:
- 0.3 × 106 CD22-CAR T cells per kg body weight (n=6)
- 1 × 106 cells per kg (n=13)
- 3 × 106 cells per kg (n=2).
There was 1 dose-limiting toxicity (DLT) at the first dose level. It was grade 3, self-limited, noninfectious diarrhea that occurred during CRS and resolved with supportive care.
The other DLT occurred in a patient who received treatment at the third dose level. This patient had grade 4 hypoxia that was associated with rapid disease progression. The patient required brief intubation, and the hypoxia was resolved within 24 hours of starting steroid treatment.
Based on these results, the second dose level became the recommended phase 2 dose.
Other adverse events
The researchers said the primary toxicity was CRS, which occurred in 16 patients. Nine patients had grade 1 CRS, and 7 had grade 2.
There were no cases of irreversible neurotoxicity or seizure reported. Among the first 16 patients with complete assessments, there were cases of transient visual hallucinations (n=2), mild unresponsiveness (n=1), mild disorientation (n=1), and mild to moderate pain (n=2). However, these incidents resolved by day 28.
One patient died from gram-negative rod sepsis that developed after the resolution of CRS and neutrophil count recovery to >1000 cells/μL blood. The patient had a history of multi-organ failure due to sepsis.
Response
Twelve patients (57%) had a CR, and 9 of them were minimal residual disease negative.
One CR occurred at the lowest dose of therapy, 1 occurred at the highest dose, and the remaining 10 CRs occurred in patients who received dose level 2.
The researchers said there was no evidence to suggest that previous CD19-directed immunotherapy or diminished surface expression of CD19 impacted response to the CD22-CAR T-cell therapy.
Of the 9 patients who did not respond, 4 progressed and 5 had stable disease.
The researchers said 4 non-responders had “very high disease burden with rapid disease progression.” And 2 non-responders expressed diminished or partial CD22 on leukemic blasts at the time of enrollment.
The median duration of response was 6 months (range, 1.5 to 21+ months). Three patients are still in CR at 6, 9, and 21 months of follow-up.
“The take-home message is that we’ve found another CAR T-cell therapy that displays high-level activity in this phase 1 trial,” Dr Mackall said. “But the relapse rate was also high. So this forces the field to get even more sophisticated. How much of a target is needed for successful, long-lasting treatment? What happens if we target both CD19 and CD22 simultaneously?”
The researchers are already tackling the last question by testing a CAR T-cell therapy that recognizes both CD19 and CD22. They’ve confirmed this therapy can kill cancer cells in vitro and in vivo. Now, they’re testing it in a clinical trial that has opened at Stanford University and will open soon at the National Cancer Institute.
*This research was supported, in part, by the Intramural Research Program, National Cancer Institute and NIH Clinical Center, National Institutes of Health; by a Stand Up to Cancer–St. Baldrick’s Pediatric Dream Team translational research grant; and by a St. Baldrick’s Foundation Scholar Award.
Researchers say they have reported the first results demonstrating clinical activity of a CD22-directed chimeric antigen receptor (CAR) T-cell therapy in B-cell acute lymphoblastic leukemia (B-ALL).
The team conducted a phase 1 study of the therapy in 21 children and adults with relapsed/refractory B-ALL.
Twelve patients achieved a complete response (CR) to the treatment, with 3 patients still in CR at last follow-up.
Sixteen patients developed cytokine release syndrome (CRS), all grade 1 or 2.
Crystal Mackall, MD, of Stanford University in California, and her colleagues reported these results in Nature Medicine.*
“This is the first time that we’ve seen response rates anything like we achieved when we were first testing the CD19 CAR T therapy,” Dr Mackall said.
“We were all a little worried that we wouldn’t find anything comparable, but this study gives hope to the idea that there may be another similar, very potent treatment.”
Patients
Dr Mackall and her colleagues studied the CD22-CAR T-cell therapy in 21 patients with relapsed/refractory B-ALL. They had a median age of 19 (range, 7 to 30).
All of the patients had received a hematopoietic stem cell transplant at least once, and 2 patients had 2 prior transplants each. Seventeen patients had received prior CD19-directed immunotherapy. Fifteen had received CD19-directed CAR T-cell therapy, and 2 had received blinatumomab.
Lymphoblasts were CD19− or CD19dim in 10 patients (9 who had received a CD19-CAR and 1 treated with blinatumomab).
The median CD22 site density was 2839 molecules per cell (range, 613 to 13,452).
Dosing and DLTs
Patients received the CD22-CAR T-cell therapy at 1 of 3 dose levels:
- 0.3 × 106 CD22-CAR T cells per kg body weight (n=6)
- 1 × 106 cells per kg (n=13)
- 3 × 106 cells per kg (n=2).
There was 1 dose-limiting toxicity (DLT) at the first dose level. It was grade 3, self-limited, noninfectious diarrhea that occurred during CRS and resolved with supportive care.
The other DLT occurred in a patient who received treatment at the third dose level. This patient had grade 4 hypoxia that was associated with rapid disease progression. The patient required brief intubation, and the hypoxia was resolved within 24 hours of starting steroid treatment.
Based on these results, the second dose level became the recommended phase 2 dose.
Other adverse events
The researchers said the primary toxicity was CRS, which occurred in 16 patients. Nine patients had grade 1 CRS, and 7 had grade 2.
There were no cases of irreversible neurotoxicity or seizure reported. Among the first 16 patients with complete assessments, there were cases of transient visual hallucinations (n=2), mild unresponsiveness (n=1), mild disorientation (n=1), and mild to moderate pain (n=2). However, these incidents resolved by day 28.
One patient died from gram-negative rod sepsis that developed after the resolution of CRS and neutrophil count recovery to >1000 cells/μL blood. The patient had a history of multi-organ failure due to sepsis.
Response
Twelve patients (57%) had a CR, and 9 of them were minimal residual disease negative.
One CR occurred at the lowest dose of therapy, 1 occurred at the highest dose, and the remaining 10 CRs occurred in patients who received dose level 2.
The researchers said there was no evidence to suggest that previous CD19-directed immunotherapy or diminished surface expression of CD19 impacted response to the CD22-CAR T-cell therapy.
Of the 9 patients who did not respond, 4 progressed and 5 had stable disease.
The researchers said 4 non-responders had “very high disease burden with rapid disease progression.” And 2 non-responders expressed diminished or partial CD22 on leukemic blasts at the time of enrollment.
The median duration of response was 6 months (range, 1.5 to 21+ months). Three patients are still in CR at 6, 9, and 21 months of follow-up.
“The take-home message is that we’ve found another CAR T-cell therapy that displays high-level activity in this phase 1 trial,” Dr Mackall said. “But the relapse rate was also high. So this forces the field to get even more sophisticated. How much of a target is needed for successful, long-lasting treatment? What happens if we target both CD19 and CD22 simultaneously?”
The researchers are already tackling the last question by testing a CAR T-cell therapy that recognizes both CD19 and CD22. They’ve confirmed this therapy can kill cancer cells in vitro and in vivo. Now, they’re testing it in a clinical trial that has opened at Stanford University and will open soon at the National Cancer Institute.
*This research was supported, in part, by the Intramural Research Program, National Cancer Institute and NIH Clinical Center, National Institutes of Health; by a Stand Up to Cancer–St. Baldrick’s Pediatric Dream Team translational research grant; and by a St. Baldrick’s Foundation Scholar Award.
FDA approves epinephrine autoinjector for infants, small children
The Food and Drug Administration approved an epinephrine autoinjector constructed specifically to treat life-threatening allergic reactions in infants and small children weighing 16.5-33 pounds.
The Auvi-Q 0.1 mg autoinjector by kaléo was approved after a priority review by the FDA, with features such as “a voice prompt system that guides a user with step-by-step instructions through the delivery process,” according to a written statement from the company. This auto-injector has a shorter needle length and lower dose of epinephrine than other FDA-approved 0.15-mg and 0.3-mg epinephrine autoinjectors.
In a previous study of 51 infants with a mean weight of 24 pounds who were treated with a 0.15-mg epinephrine auto-injector with a standard 12.7-mm needle length, 43% were at risk of having the needle strike the bone. Unintentional injection of epinephrine into the intraosseous space can cause systemic absorption of the epinephrine and possible cardiac complications (Ann Allergy Asthma Immunol. 2017 Jun;118[6]:719-25.e1).
This new autoinjector with a shorter needle length was designed to obviate this problem, according to kaléo’s statement.
The Auvi-Q 0.1 mg autoinjector should be available to patients in the first half of 2018, the company said.
The Food and Drug Administration approved an epinephrine autoinjector constructed specifically to treat life-threatening allergic reactions in infants and small children weighing 16.5-33 pounds.
The Auvi-Q 0.1 mg autoinjector by kaléo was approved after a priority review by the FDA, with features such as “a voice prompt system that guides a user with step-by-step instructions through the delivery process,” according to a written statement from the company. This auto-injector has a shorter needle length and lower dose of epinephrine than other FDA-approved 0.15-mg and 0.3-mg epinephrine autoinjectors.
In a previous study of 51 infants with a mean weight of 24 pounds who were treated with a 0.15-mg epinephrine auto-injector with a standard 12.7-mm needle length, 43% were at risk of having the needle strike the bone. Unintentional injection of epinephrine into the intraosseous space can cause systemic absorption of the epinephrine and possible cardiac complications (Ann Allergy Asthma Immunol. 2017 Jun;118[6]:719-25.e1).
This new autoinjector with a shorter needle length was designed to obviate this problem, according to kaléo’s statement.
The Auvi-Q 0.1 mg autoinjector should be available to patients in the first half of 2018, the company said.
The Food and Drug Administration approved an epinephrine autoinjector constructed specifically to treat life-threatening allergic reactions in infants and small children weighing 16.5-33 pounds.
The Auvi-Q 0.1 mg autoinjector by kaléo was approved after a priority review by the FDA, with features such as “a voice prompt system that guides a user with step-by-step instructions through the delivery process,” according to a written statement from the company. This auto-injector has a shorter needle length and lower dose of epinephrine than other FDA-approved 0.15-mg and 0.3-mg epinephrine autoinjectors.
In a previous study of 51 infants with a mean weight of 24 pounds who were treated with a 0.15-mg epinephrine auto-injector with a standard 12.7-mm needle length, 43% were at risk of having the needle strike the bone. Unintentional injection of epinephrine into the intraosseous space can cause systemic absorption of the epinephrine and possible cardiac complications (Ann Allergy Asthma Immunol. 2017 Jun;118[6]:719-25.e1).
This new autoinjector with a shorter needle length was designed to obviate this problem, according to kaléo’s statement.
The Auvi-Q 0.1 mg autoinjector should be available to patients in the first half of 2018, the company said.
Parents have diverse reasons for refusing HPV vaccine for their child
, so health care providers have much work to do to educate parents about this anticancer vaccine, said Frances DiAnna Kinder, PhD, RN, CPNP-PC, of the La Salle University, Philadelphia.
Pediatricians, nurse practitioners, and physician assistants from numerous private pediatric settings in Philadelphia discussed HPV vaccination during a well-child visit with parents and children who were eligible for the vaccine, which generally starts at age 9 years. After a health visit in which the HPV vaccine was refused, the parent was asked to complete a survey in a private room. Of 72 surveys by 63 mothers, 8 fathers, and 1 grandparent of children who were mostly female and mostly between ages 11-16 years, 58% said the vaccine was too new, and 50% said there was not enough research. However, 63% said they believed in the HPV vaccine’s efficacy, and all reported their child was up to date with other recommended vaccines.
There was an open-ended question for parents to indicate other reasons for refusal; some themes of refusal included fear, anxiety, and misunderstanding the facts of the HPV vaccine; 21 parents whose children were aged 11-13 years said their child was too young to be vaccinated with the HPV vaccine. Three parents said that they had “witnessed severe side effects such as becoming paralyzed” or “acquiring an autoimmune disease after the vaccine was administered” to either a family member or friend’s child, Dr. Kinder noted. One parent said, “this vaccine was a money maker for the pharmaceutical companies” and there was “too much controversy for her to be comfortable giving this to her child.”
Read more at (J Pediatr Health Care. 2017. 10.1016/j.pedhc.2017.09.003).
cnellist@frontlinemedcom.com
, so health care providers have much work to do to educate parents about this anticancer vaccine, said Frances DiAnna Kinder, PhD, RN, CPNP-PC, of the La Salle University, Philadelphia.
Pediatricians, nurse practitioners, and physician assistants from numerous private pediatric settings in Philadelphia discussed HPV vaccination during a well-child visit with parents and children who were eligible for the vaccine, which generally starts at age 9 years. After a health visit in which the HPV vaccine was refused, the parent was asked to complete a survey in a private room. Of 72 surveys by 63 mothers, 8 fathers, and 1 grandparent of children who were mostly female and mostly between ages 11-16 years, 58% said the vaccine was too new, and 50% said there was not enough research. However, 63% said they believed in the HPV vaccine’s efficacy, and all reported their child was up to date with other recommended vaccines.
There was an open-ended question for parents to indicate other reasons for refusal; some themes of refusal included fear, anxiety, and misunderstanding the facts of the HPV vaccine; 21 parents whose children were aged 11-13 years said their child was too young to be vaccinated with the HPV vaccine. Three parents said that they had “witnessed severe side effects such as becoming paralyzed” or “acquiring an autoimmune disease after the vaccine was administered” to either a family member or friend’s child, Dr. Kinder noted. One parent said, “this vaccine was a money maker for the pharmaceutical companies” and there was “too much controversy for her to be comfortable giving this to her child.”
Read more at (J Pediatr Health Care. 2017. 10.1016/j.pedhc.2017.09.003).
cnellist@frontlinemedcom.com
, so health care providers have much work to do to educate parents about this anticancer vaccine, said Frances DiAnna Kinder, PhD, RN, CPNP-PC, of the La Salle University, Philadelphia.
Pediatricians, nurse practitioners, and physician assistants from numerous private pediatric settings in Philadelphia discussed HPV vaccination during a well-child visit with parents and children who were eligible for the vaccine, which generally starts at age 9 years. After a health visit in which the HPV vaccine was refused, the parent was asked to complete a survey in a private room. Of 72 surveys by 63 mothers, 8 fathers, and 1 grandparent of children who were mostly female and mostly between ages 11-16 years, 58% said the vaccine was too new, and 50% said there was not enough research. However, 63% said they believed in the HPV vaccine’s efficacy, and all reported their child was up to date with other recommended vaccines.
There was an open-ended question for parents to indicate other reasons for refusal; some themes of refusal included fear, anxiety, and misunderstanding the facts of the HPV vaccine; 21 parents whose children were aged 11-13 years said their child was too young to be vaccinated with the HPV vaccine. Three parents said that they had “witnessed severe side effects such as becoming paralyzed” or “acquiring an autoimmune disease after the vaccine was administered” to either a family member or friend’s child, Dr. Kinder noted. One parent said, “this vaccine was a money maker for the pharmaceutical companies” and there was “too much controversy for her to be comfortable giving this to her child.”
Read more at (J Pediatr Health Care. 2017. 10.1016/j.pedhc.2017.09.003).
cnellist@frontlinemedcom.com
FROM THE JOURNAL OF PEDIATRIC HEALTH CARE
A program to increase flu vaccine compliance
. It won’t hurt your bottom line either and actually will help it. A flu shot program potentially can be run by a licensed practical nurse, registered nurse, physician’s assistant, or pediatric nurse practitioner, depending on your state’s law regarding vaccine administration by other than a physician, thus freeing up the physician to see well-child and sick-call patients.
It’s easy to set up a flu shot program and run it. Start preparing in June, preceding the upcoming flu season. Designate several Saturdays and or Sundays in September, October, November, December, and January as flu shot Saturdays and/or Sundays. And if Columbus day falls on a weekday, consider adding Columbus Day to your program dates as the kids often are off from school that day (check the local school calendar).
Next, prepare a postcard to be mailed to all patients on the lists your EMR produced for you. Keep the postcard simple. Announce the program, and state the dates the flu shot program is running. Ask parents to call to make an appointment for a flu vaccine only by appointment “with the program.” In addition to mailing a postcard, announce the flu shot program by sending out automated telephone calls and emails to all three lists the EMR has produced for you. The postcard mailing is your first contact, essentially announcing the program with dates and times. An automated phone call may be used to announce a specific date for which you are “now booking.” A good option when using automated phone calls is to allow the caller to press “zero” to be connected to the office to schedule a “flu shot only” appointment! Finally, emails announcing the dates of the program simply will reinforce information about the program.
Mr. Berman has been providing practice management services to physicians and other medical providers since 1983. He is the CEO of a pediatrics practice with locations in Staten Island and Brooklyn, N.Y. He holds a faculty appointment at State University of New York, Brooklyn, as a lecturer for the department of family medicine’s residency training program. He has no disclosures to report. Email him at pdnews@frontlinemedcom.com.
. It won’t hurt your bottom line either and actually will help it. A flu shot program potentially can be run by a licensed practical nurse, registered nurse, physician’s assistant, or pediatric nurse practitioner, depending on your state’s law regarding vaccine administration by other than a physician, thus freeing up the physician to see well-child and sick-call patients.
It’s easy to set up a flu shot program and run it. Start preparing in June, preceding the upcoming flu season. Designate several Saturdays and or Sundays in September, October, November, December, and January as flu shot Saturdays and/or Sundays. And if Columbus day falls on a weekday, consider adding Columbus Day to your program dates as the kids often are off from school that day (check the local school calendar).
Next, prepare a postcard to be mailed to all patients on the lists your EMR produced for you. Keep the postcard simple. Announce the program, and state the dates the flu shot program is running. Ask parents to call to make an appointment for a flu vaccine only by appointment “with the program.” In addition to mailing a postcard, announce the flu shot program by sending out automated telephone calls and emails to all three lists the EMR has produced for you. The postcard mailing is your first contact, essentially announcing the program with dates and times. An automated phone call may be used to announce a specific date for which you are “now booking.” A good option when using automated phone calls is to allow the caller to press “zero” to be connected to the office to schedule a “flu shot only” appointment! Finally, emails announcing the dates of the program simply will reinforce information about the program.
Mr. Berman has been providing practice management services to physicians and other medical providers since 1983. He is the CEO of a pediatrics practice with locations in Staten Island and Brooklyn, N.Y. He holds a faculty appointment at State University of New York, Brooklyn, as a lecturer for the department of family medicine’s residency training program. He has no disclosures to report. Email him at pdnews@frontlinemedcom.com.
. It won’t hurt your bottom line either and actually will help it. A flu shot program potentially can be run by a licensed practical nurse, registered nurse, physician’s assistant, or pediatric nurse practitioner, depending on your state’s law regarding vaccine administration by other than a physician, thus freeing up the physician to see well-child and sick-call patients.
It’s easy to set up a flu shot program and run it. Start preparing in June, preceding the upcoming flu season. Designate several Saturdays and or Sundays in September, October, November, December, and January as flu shot Saturdays and/or Sundays. And if Columbus day falls on a weekday, consider adding Columbus Day to your program dates as the kids often are off from school that day (check the local school calendar).
Next, prepare a postcard to be mailed to all patients on the lists your EMR produced for you. Keep the postcard simple. Announce the program, and state the dates the flu shot program is running. Ask parents to call to make an appointment for a flu vaccine only by appointment “with the program.” In addition to mailing a postcard, announce the flu shot program by sending out automated telephone calls and emails to all three lists the EMR has produced for you. The postcard mailing is your first contact, essentially announcing the program with dates and times. An automated phone call may be used to announce a specific date for which you are “now booking.” A good option when using automated phone calls is to allow the caller to press “zero” to be connected to the office to schedule a “flu shot only” appointment! Finally, emails announcing the dates of the program simply will reinforce information about the program.
Mr. Berman has been providing practice management services to physicians and other medical providers since 1983. He is the CEO of a pediatrics practice with locations in Staten Island and Brooklyn, N.Y. He holds a faculty appointment at State University of New York, Brooklyn, as a lecturer for the department of family medicine’s residency training program. He has no disclosures to report. Email him at pdnews@frontlinemedcom.com.
Two changes are made to resuscitation practice in delivery room
CHICAGO – , according to Gary M. Weiner, MD, of the department of pediatrics and neonatal-perinatal medicine at the University of Michigan and C.S. Mott Children’s Hospital in Ann Arbor.
One is recommending an electronic cardiac (EC) monitor to assess heart rate during resuscitation instead of relying on pulse oximetry, and the other is no longer recommending routine tracheal suction in nonvigorous babies with meconium-stained fluid, he told attendees at the American Academy of Pediatrics annual meeting.
About two-thirds of all births have a risk factor for needing resuscitation, and about 10%-20% of babies with a risk factor will need positive pressure ventilation (PPV). But risk factors do not identify all newborns who will need it. The risk is greatest for newborns less than 36 weeks’ or greater than 40 weeks’ gestational age, but 7% of term newborns will need PPV despite having no risk factors.
Situations in which there is the highest risk for advanced resuscitation include the following:
- Fetal bradycardia: 24-fold greater odds.
- Intrauterine growth restriction (IUGR): 20-fold greater odds.
- Clinical chorioamnionitis: 17-fold greater odds.
- Forceps or vacuum: 17-fold greater odds.
- Meconium-stained amniotic fluid (MSAF): 17-fold greater odds.
- Gestational diabetes: 16-fold greater odds.
- Abruption: 12-fold greater odds.
- General anesthesia: 11-fold greater odds.
These risks were determined in a prospective multicenter, case-control study of 61,593 births (Arch Dis Child Fetal Neonatal Ed. 2017 Jan;102[1]:F44-F50).
Assembling a team and using checklists
Teamwork and communication are key in delivery room emergencies, and teams should debrief afterward, ideally having videotaped the resuscitation, if possible, Dr. Weiner said.
He discussed preparation for a very-low-birth-weight birth, a “routine emergency” requiring many tasks in a short period of time: 130 tasks in the first hour and 40 in the first 3 minutes.
“Decisions made during the first hour have long-term implications, so you need multiple caregivers and a high-performance team,” Dr. Weiner said. In addition to a thorough understanding of the clinical situation, a high-performance team should have both effective leadership, and clearly defined roles and responsibilities for each member. Clinicians on the team need highly developed technical skills that they reliably and consistently execute with precision. “Practice, refine, practice, refine,” he emphasized.
It’s also important to make use of preset protocols, scripts, and checklists, Dr. Weiner said. These tools assure consistency, facilitate communication among team members, and improve outcomes. Research has shown that use of protocols, scripts, and checklists leads to improved stroke and trauma care, decreased complications during intubation, fewer central-line complications, and decreased perioperative mortality and complications.
He also recommended implementing a standardized equipment check and team briefing “time-out,” similar to a surgical time-out. This time-out gives teams an opportunity to identify a team leader, define member roles and responsibilities, check all equipment and supplies, discuss risk factors and possible scenarios, talk with the obstetrician and, if possible, introduce the leader or another team member to the parents.
In a study from University of California, San Diego, Medical Center, using checklists as part of resuscitation of potentially high-risk infants reduced the occurrence of communication problems from 24% to 4% of resuscitations (P less than 0.001) over a 3-year period (Resuscitation. 2013 Nov;84[11]:1552-7).
Delayed cord clamping
Dr. Weiner also discussed the benefits of placental transfusion. The fetal-placental unit includes approximately 110 mL/kg of blood, and about one-third of its volume remains in the placenta immediately after birth. Immediate cord clamping means a loss of 10-20 mL/kg of “potential” newborn blood volume, and could contribute to unstable pulmonary blood flow or a carotid artery pressure spike (Matern Health Neonatol Perinatol. 2016. doi: 10.1186/s40748-016-0032-y).
“Umbilical blood flow is complex,” he said. Blood flows toward the baby via the umbilical vein during inhalation, but stops or reverses during crying. The umbilical artery primarily carries blood to the placenta, and flow stops after about 4 minutes in more than half of infants. Gravity’s role in blood flow is controversial (Lancet. 2014 Jul 19;384[9939]:235-40).
The two options for placental transfusion are delayed cord clamping and milking the umbilical cord (also called “stripping”). In vaginal births, delayed clamping allows 20 mL/kg blood to transfer to the baby by 3 minutes after birth, with 90% of that reaching the baby in the first minute (Lancet. 1969 Oct 25;294[7626]:871-3).
Blood transfer is less efficient in cesarean births, so milking may be more efficient than simply delaying clamping, according to a small randomized controlled trial of preterm infants around 28 weeks’ gestational age. No difference between the methods was seen in vaginal births. To milk the cord, pinch it near the placenta and squeeze it toward the newborn for 2 seconds; then release, refill and repeat.
The biggest benefits in delayed cord clamping or milking occur among preterm infants: decreased mortality, higher mean arterial pressure on day 1, and a lower risk of blood transfusion, necrotizing enterocolitis, and a Bayley Motor score below 85 at 18-22 months. Term babies also get benefits, though: increased hemoglobin at birth (approximately 2 g/dL), a 0.5- to 5-point average increase in boys’ Ages & Stages fine motor and social domain scores at age 4 years, and among high-risk infants, a lower risk of iron deficiency anemia at age 1 year (JAMA Pediatr. 2017;171[3]:264-70).
According to current guidelines from the American Academy of Pediatrics, “delayed cord clamping longer than 30 seconds is reasonable for both term and preterm infants who do not require resuscitation at birth,” but “there is insufficient evidence to recommend an approach to cord clamping for infants who require resuscitation.” They also recommend against routine milking for newborns less than 29 weeks’ gestation (Pediatrics. 2015 Nov;136 Suppl 2:S196-218).
Meconium-related complications
Meconium-stained amniotic fluid (MSAF) is common, occurring in about 8% of deliveries and increasing with gestational age, but meconium aspiration syndrome (MAS) is less common, occurring in about 2% of all MSAF cases (Int J Pediatr. 2012. doi: 10.1155/2012/321545).
Risk factors for severe MAS include thick meconium and an abnormal fetal heart rate. But about two-thirds of MAS cases are mild, not requiring ventilation or continuous positive airway pressure (CPAP), Dr. Weiner said. Practice should be driven by evidence from randomized controlled trials (RCTs).
“Nonrandomized observational studies can be misleading, and rational conjecture has led to many mistakes in medicine,” he said. “Be willing to challenge conventional wisdom.”
For example, the standard of care in the 1970s, based on two nonrandomized retrospective reviews of 175 babies, included orapharyngeal and nasopharyngeal suction by the obstetrician and endotracheal tube (ETT) suction by the pediatrician. In the 2000s, however, an RCT of 2,500 infants found no benefit from orapharyngeal and nasopharyngeal suction, even with thick MSAF, (Lancet. 2004 Aug 14-20;364[9434]:597-602) and another RCT with 2,100 infants found no benefit from ETT suction (Pediatrics. 2000 Jan;105[1 Pt 1]:1-7).
More recent, smaller studies have confirmed those conclusions and found similar lack of benefit from ETT in non-vigorous infants, contributing to the new recommendation (Resuscitation. 2016 Aug;105:79-84; Indian J Pediatr. 2016 Oct;83[10]:1125-30).
“Routine tracheal suction is no longer recommended for nonvigorous babies with meconium stained fluid,” Dr. Weiner said. Since MSAF is risk factor for resuscitation, though, at least two clinicians with Neonatal Resuscitation Program (NRP) training should be present, as well as a full team if resuscitation is expected.
Heart rate assessment and tracking
“The baby’s heart rate needs to be monitored during PPV [positive pressure ventilation] because a prompt increase in the baby’s heart rate is the most important indicator of effective PPV,” Dr. Weiner said in an interview. “Half of errors made during NRP [Neonatal Resuscitation Program] simulations are the result of incorrect heart rate assessment.”
Recent evidence comparing pulse oximetry to an EC monitor favored the latter for tracking heart rate, leading to the other new recommendation.
“The baby’s heart rate can be monitored using the pulse oximeter,” Dr. Weiner said. “However, health providers should consider using an electronic cardiac monitor in addition to pulse oximetry because studies show that it achieves a reliable signal faster.” He cited a study of 20 newborns that showed an EC monitor determined the heart rate in a median 34 seconds, compared with 122 seconds with the pulse oximeter (Pediatr Int. 2012 Apr;54[2]:205-7).
Pulse oximetry takes 90-120 seconds to attain a reliable signal and may not work if there’s poor perfusion, but an EC monitor provides continuous heart rate monitoring even with poor perfusion. So an initial heart rate assessment by auscultation is fine, but if PPV begins, EC monitoring may be better and is the preferred method with anticipated resuscitation or chest compressions.
However, pulse oximetry is still recommended “whenever positive pressure ventilation is started or oxygen is administered in order to guide the appropriate amount of oxygen supplementation,” Dr. Weiner noted.
He added that “preliminary studies suggest that handheld Doppler fetal heart monitors correlate well with ECG, provide a rapid audible heart rate and may be a promising alternative in the future” (Pediatr Int. 2017 Oct;59[10]:1069-73).
Correct ventilation techniques
“Ventilation of the lungs is the single most important and most effective step in cardiopulmonary resuscitation of the compromised newborn,” Dr. Weiner said. “If the heart rate is not rapidly increasing, ask if the chest is moving.”
He emphasized that no compressions should occur until after at least 30 seconds of PPV that moves the chest. He provided a “MR. SOPA” acronym: Mask adjustment, Reposition airway, Suction, Open mouth, Pressure increase, Alternative airway.
You also should be aware of possible leaking or obstruction around the mask, which is common, he said, so monitor pressure instead of volume.
“We are not good at identifying leak, obstruction, or adequate tidal volume,” Dr. Weiner said. “A colorimetric CO2 detector attached to the mask is a simple indicator of gas exchange” (Resuscitation. 2014 Nov;85[11]:1568-72).
He also strongly recommended inserting an alternative airway before starting chest compressions with either intubation or a laryngeal mask.
Dr. Weiner concluded with the following list of clinical practice changes you may consider:
- Use a standardized equipment checklist.
- Develop and practice standardized scripts.
- Debrief after all resuscitations; use videotape if you can.
- Delay cord clamping for most term and preterm babies.
- Do not routinely intubate/suction nonvigorous newborns with MSAF. Initiate resuscitation.
- Use an electronic cardiac monitor if resuscitation is required.
- Use a colorimetric CO2 detector with PPV.
- Intubate or place a laryngeal mask before starting compressions.
Dr. Weiner reported having no disclosures, and no external funding was used for the presentation.
CHICAGO – , according to Gary M. Weiner, MD, of the department of pediatrics and neonatal-perinatal medicine at the University of Michigan and C.S. Mott Children’s Hospital in Ann Arbor.
One is recommending an electronic cardiac (EC) monitor to assess heart rate during resuscitation instead of relying on pulse oximetry, and the other is no longer recommending routine tracheal suction in nonvigorous babies with meconium-stained fluid, he told attendees at the American Academy of Pediatrics annual meeting.
About two-thirds of all births have a risk factor for needing resuscitation, and about 10%-20% of babies with a risk factor will need positive pressure ventilation (PPV). But risk factors do not identify all newborns who will need it. The risk is greatest for newborns less than 36 weeks’ or greater than 40 weeks’ gestational age, but 7% of term newborns will need PPV despite having no risk factors.
Situations in which there is the highest risk for advanced resuscitation include the following:
- Fetal bradycardia: 24-fold greater odds.
- Intrauterine growth restriction (IUGR): 20-fold greater odds.
- Clinical chorioamnionitis: 17-fold greater odds.
- Forceps or vacuum: 17-fold greater odds.
- Meconium-stained amniotic fluid (MSAF): 17-fold greater odds.
- Gestational diabetes: 16-fold greater odds.
- Abruption: 12-fold greater odds.
- General anesthesia: 11-fold greater odds.
These risks were determined in a prospective multicenter, case-control study of 61,593 births (Arch Dis Child Fetal Neonatal Ed. 2017 Jan;102[1]:F44-F50).
Assembling a team and using checklists
Teamwork and communication are key in delivery room emergencies, and teams should debrief afterward, ideally having videotaped the resuscitation, if possible, Dr. Weiner said.
He discussed preparation for a very-low-birth-weight birth, a “routine emergency” requiring many tasks in a short period of time: 130 tasks in the first hour and 40 in the first 3 minutes.
“Decisions made during the first hour have long-term implications, so you need multiple caregivers and a high-performance team,” Dr. Weiner said. In addition to a thorough understanding of the clinical situation, a high-performance team should have both effective leadership, and clearly defined roles and responsibilities for each member. Clinicians on the team need highly developed technical skills that they reliably and consistently execute with precision. “Practice, refine, practice, refine,” he emphasized.
It’s also important to make use of preset protocols, scripts, and checklists, Dr. Weiner said. These tools assure consistency, facilitate communication among team members, and improve outcomes. Research has shown that use of protocols, scripts, and checklists leads to improved stroke and trauma care, decreased complications during intubation, fewer central-line complications, and decreased perioperative mortality and complications.
He also recommended implementing a standardized equipment check and team briefing “time-out,” similar to a surgical time-out. This time-out gives teams an opportunity to identify a team leader, define member roles and responsibilities, check all equipment and supplies, discuss risk factors and possible scenarios, talk with the obstetrician and, if possible, introduce the leader or another team member to the parents.
In a study from University of California, San Diego, Medical Center, using checklists as part of resuscitation of potentially high-risk infants reduced the occurrence of communication problems from 24% to 4% of resuscitations (P less than 0.001) over a 3-year period (Resuscitation. 2013 Nov;84[11]:1552-7).
Delayed cord clamping
Dr. Weiner also discussed the benefits of placental transfusion. The fetal-placental unit includes approximately 110 mL/kg of blood, and about one-third of its volume remains in the placenta immediately after birth. Immediate cord clamping means a loss of 10-20 mL/kg of “potential” newborn blood volume, and could contribute to unstable pulmonary blood flow or a carotid artery pressure spike (Matern Health Neonatol Perinatol. 2016. doi: 10.1186/s40748-016-0032-y).
“Umbilical blood flow is complex,” he said. Blood flows toward the baby via the umbilical vein during inhalation, but stops or reverses during crying. The umbilical artery primarily carries blood to the placenta, and flow stops after about 4 minutes in more than half of infants. Gravity’s role in blood flow is controversial (Lancet. 2014 Jul 19;384[9939]:235-40).
The two options for placental transfusion are delayed cord clamping and milking the umbilical cord (also called “stripping”). In vaginal births, delayed clamping allows 20 mL/kg blood to transfer to the baby by 3 minutes after birth, with 90% of that reaching the baby in the first minute (Lancet. 1969 Oct 25;294[7626]:871-3).
Blood transfer is less efficient in cesarean births, so milking may be more efficient than simply delaying clamping, according to a small randomized controlled trial of preterm infants around 28 weeks’ gestational age. No difference between the methods was seen in vaginal births. To milk the cord, pinch it near the placenta and squeeze it toward the newborn for 2 seconds; then release, refill and repeat.
The biggest benefits in delayed cord clamping or milking occur among preterm infants: decreased mortality, higher mean arterial pressure on day 1, and a lower risk of blood transfusion, necrotizing enterocolitis, and a Bayley Motor score below 85 at 18-22 months. Term babies also get benefits, though: increased hemoglobin at birth (approximately 2 g/dL), a 0.5- to 5-point average increase in boys’ Ages & Stages fine motor and social domain scores at age 4 years, and among high-risk infants, a lower risk of iron deficiency anemia at age 1 year (JAMA Pediatr. 2017;171[3]:264-70).
According to current guidelines from the American Academy of Pediatrics, “delayed cord clamping longer than 30 seconds is reasonable for both term and preterm infants who do not require resuscitation at birth,” but “there is insufficient evidence to recommend an approach to cord clamping for infants who require resuscitation.” They also recommend against routine milking for newborns less than 29 weeks’ gestation (Pediatrics. 2015 Nov;136 Suppl 2:S196-218).
Meconium-related complications
Meconium-stained amniotic fluid (MSAF) is common, occurring in about 8% of deliveries and increasing with gestational age, but meconium aspiration syndrome (MAS) is less common, occurring in about 2% of all MSAF cases (Int J Pediatr. 2012. doi: 10.1155/2012/321545).
Risk factors for severe MAS include thick meconium and an abnormal fetal heart rate. But about two-thirds of MAS cases are mild, not requiring ventilation or continuous positive airway pressure (CPAP), Dr. Weiner said. Practice should be driven by evidence from randomized controlled trials (RCTs).
“Nonrandomized observational studies can be misleading, and rational conjecture has led to many mistakes in medicine,” he said. “Be willing to challenge conventional wisdom.”
For example, the standard of care in the 1970s, based on two nonrandomized retrospective reviews of 175 babies, included orapharyngeal and nasopharyngeal suction by the obstetrician and endotracheal tube (ETT) suction by the pediatrician. In the 2000s, however, an RCT of 2,500 infants found no benefit from orapharyngeal and nasopharyngeal suction, even with thick MSAF, (Lancet. 2004 Aug 14-20;364[9434]:597-602) and another RCT with 2,100 infants found no benefit from ETT suction (Pediatrics. 2000 Jan;105[1 Pt 1]:1-7).
More recent, smaller studies have confirmed those conclusions and found similar lack of benefit from ETT in non-vigorous infants, contributing to the new recommendation (Resuscitation. 2016 Aug;105:79-84; Indian J Pediatr. 2016 Oct;83[10]:1125-30).
“Routine tracheal suction is no longer recommended for nonvigorous babies with meconium stained fluid,” Dr. Weiner said. Since MSAF is risk factor for resuscitation, though, at least two clinicians with Neonatal Resuscitation Program (NRP) training should be present, as well as a full team if resuscitation is expected.
Heart rate assessment and tracking
“The baby’s heart rate needs to be monitored during PPV [positive pressure ventilation] because a prompt increase in the baby’s heart rate is the most important indicator of effective PPV,” Dr. Weiner said in an interview. “Half of errors made during NRP [Neonatal Resuscitation Program] simulations are the result of incorrect heart rate assessment.”
Recent evidence comparing pulse oximetry to an EC monitor favored the latter for tracking heart rate, leading to the other new recommendation.
“The baby’s heart rate can be monitored using the pulse oximeter,” Dr. Weiner said. “However, health providers should consider using an electronic cardiac monitor in addition to pulse oximetry because studies show that it achieves a reliable signal faster.” He cited a study of 20 newborns that showed an EC monitor determined the heart rate in a median 34 seconds, compared with 122 seconds with the pulse oximeter (Pediatr Int. 2012 Apr;54[2]:205-7).
Pulse oximetry takes 90-120 seconds to attain a reliable signal and may not work if there’s poor perfusion, but an EC monitor provides continuous heart rate monitoring even with poor perfusion. So an initial heart rate assessment by auscultation is fine, but if PPV begins, EC monitoring may be better and is the preferred method with anticipated resuscitation or chest compressions.
However, pulse oximetry is still recommended “whenever positive pressure ventilation is started or oxygen is administered in order to guide the appropriate amount of oxygen supplementation,” Dr. Weiner noted.
He added that “preliminary studies suggest that handheld Doppler fetal heart monitors correlate well with ECG, provide a rapid audible heart rate and may be a promising alternative in the future” (Pediatr Int. 2017 Oct;59[10]:1069-73).
Correct ventilation techniques
“Ventilation of the lungs is the single most important and most effective step in cardiopulmonary resuscitation of the compromised newborn,” Dr. Weiner said. “If the heart rate is not rapidly increasing, ask if the chest is moving.”
He emphasized that no compressions should occur until after at least 30 seconds of PPV that moves the chest. He provided a “MR. SOPA” acronym: Mask adjustment, Reposition airway, Suction, Open mouth, Pressure increase, Alternative airway.
You also should be aware of possible leaking or obstruction around the mask, which is common, he said, so monitor pressure instead of volume.
“We are not good at identifying leak, obstruction, or adequate tidal volume,” Dr. Weiner said. “A colorimetric CO2 detector attached to the mask is a simple indicator of gas exchange” (Resuscitation. 2014 Nov;85[11]:1568-72).
He also strongly recommended inserting an alternative airway before starting chest compressions with either intubation or a laryngeal mask.
Dr. Weiner concluded with the following list of clinical practice changes you may consider:
- Use a standardized equipment checklist.
- Develop and practice standardized scripts.
- Debrief after all resuscitations; use videotape if you can.
- Delay cord clamping for most term and preterm babies.
- Do not routinely intubate/suction nonvigorous newborns with MSAF. Initiate resuscitation.
- Use an electronic cardiac monitor if resuscitation is required.
- Use a colorimetric CO2 detector with PPV.
- Intubate or place a laryngeal mask before starting compressions.
Dr. Weiner reported having no disclosures, and no external funding was used for the presentation.
CHICAGO – , according to Gary M. Weiner, MD, of the department of pediatrics and neonatal-perinatal medicine at the University of Michigan and C.S. Mott Children’s Hospital in Ann Arbor.
One is recommending an electronic cardiac (EC) monitor to assess heart rate during resuscitation instead of relying on pulse oximetry, and the other is no longer recommending routine tracheal suction in nonvigorous babies with meconium-stained fluid, he told attendees at the American Academy of Pediatrics annual meeting.
About two-thirds of all births have a risk factor for needing resuscitation, and about 10%-20% of babies with a risk factor will need positive pressure ventilation (PPV). But risk factors do not identify all newborns who will need it. The risk is greatest for newborns less than 36 weeks’ or greater than 40 weeks’ gestational age, but 7% of term newborns will need PPV despite having no risk factors.
Situations in which there is the highest risk for advanced resuscitation include the following:
- Fetal bradycardia: 24-fold greater odds.
- Intrauterine growth restriction (IUGR): 20-fold greater odds.
- Clinical chorioamnionitis: 17-fold greater odds.
- Forceps or vacuum: 17-fold greater odds.
- Meconium-stained amniotic fluid (MSAF): 17-fold greater odds.
- Gestational diabetes: 16-fold greater odds.
- Abruption: 12-fold greater odds.
- General anesthesia: 11-fold greater odds.
These risks were determined in a prospective multicenter, case-control study of 61,593 births (Arch Dis Child Fetal Neonatal Ed. 2017 Jan;102[1]:F44-F50).
Assembling a team and using checklists
Teamwork and communication are key in delivery room emergencies, and teams should debrief afterward, ideally having videotaped the resuscitation, if possible, Dr. Weiner said.
He discussed preparation for a very-low-birth-weight birth, a “routine emergency” requiring many tasks in a short period of time: 130 tasks in the first hour and 40 in the first 3 minutes.
“Decisions made during the first hour have long-term implications, so you need multiple caregivers and a high-performance team,” Dr. Weiner said. In addition to a thorough understanding of the clinical situation, a high-performance team should have both effective leadership, and clearly defined roles and responsibilities for each member. Clinicians on the team need highly developed technical skills that they reliably and consistently execute with precision. “Practice, refine, practice, refine,” he emphasized.
It’s also important to make use of preset protocols, scripts, and checklists, Dr. Weiner said. These tools assure consistency, facilitate communication among team members, and improve outcomes. Research has shown that use of protocols, scripts, and checklists leads to improved stroke and trauma care, decreased complications during intubation, fewer central-line complications, and decreased perioperative mortality and complications.
He also recommended implementing a standardized equipment check and team briefing “time-out,” similar to a surgical time-out. This time-out gives teams an opportunity to identify a team leader, define member roles and responsibilities, check all equipment and supplies, discuss risk factors and possible scenarios, talk with the obstetrician and, if possible, introduce the leader or another team member to the parents.
In a study from University of California, San Diego, Medical Center, using checklists as part of resuscitation of potentially high-risk infants reduced the occurrence of communication problems from 24% to 4% of resuscitations (P less than 0.001) over a 3-year period (Resuscitation. 2013 Nov;84[11]:1552-7).
Delayed cord clamping
Dr. Weiner also discussed the benefits of placental transfusion. The fetal-placental unit includes approximately 110 mL/kg of blood, and about one-third of its volume remains in the placenta immediately after birth. Immediate cord clamping means a loss of 10-20 mL/kg of “potential” newborn blood volume, and could contribute to unstable pulmonary blood flow or a carotid artery pressure spike (Matern Health Neonatol Perinatol. 2016. doi: 10.1186/s40748-016-0032-y).
“Umbilical blood flow is complex,” he said. Blood flows toward the baby via the umbilical vein during inhalation, but stops or reverses during crying. The umbilical artery primarily carries blood to the placenta, and flow stops after about 4 minutes in more than half of infants. Gravity’s role in blood flow is controversial (Lancet. 2014 Jul 19;384[9939]:235-40).
The two options for placental transfusion are delayed cord clamping and milking the umbilical cord (also called “stripping”). In vaginal births, delayed clamping allows 20 mL/kg blood to transfer to the baby by 3 minutes after birth, with 90% of that reaching the baby in the first minute (Lancet. 1969 Oct 25;294[7626]:871-3).
Blood transfer is less efficient in cesarean births, so milking may be more efficient than simply delaying clamping, according to a small randomized controlled trial of preterm infants around 28 weeks’ gestational age. No difference between the methods was seen in vaginal births. To milk the cord, pinch it near the placenta and squeeze it toward the newborn for 2 seconds; then release, refill and repeat.
The biggest benefits in delayed cord clamping or milking occur among preterm infants: decreased mortality, higher mean arterial pressure on day 1, and a lower risk of blood transfusion, necrotizing enterocolitis, and a Bayley Motor score below 85 at 18-22 months. Term babies also get benefits, though: increased hemoglobin at birth (approximately 2 g/dL), a 0.5- to 5-point average increase in boys’ Ages & Stages fine motor and social domain scores at age 4 years, and among high-risk infants, a lower risk of iron deficiency anemia at age 1 year (JAMA Pediatr. 2017;171[3]:264-70).
According to current guidelines from the American Academy of Pediatrics, “delayed cord clamping longer than 30 seconds is reasonable for both term and preterm infants who do not require resuscitation at birth,” but “there is insufficient evidence to recommend an approach to cord clamping for infants who require resuscitation.” They also recommend against routine milking for newborns less than 29 weeks’ gestation (Pediatrics. 2015 Nov;136 Suppl 2:S196-218).
Meconium-related complications
Meconium-stained amniotic fluid (MSAF) is common, occurring in about 8% of deliveries and increasing with gestational age, but meconium aspiration syndrome (MAS) is less common, occurring in about 2% of all MSAF cases (Int J Pediatr. 2012. doi: 10.1155/2012/321545).
Risk factors for severe MAS include thick meconium and an abnormal fetal heart rate. But about two-thirds of MAS cases are mild, not requiring ventilation or continuous positive airway pressure (CPAP), Dr. Weiner said. Practice should be driven by evidence from randomized controlled trials (RCTs).
“Nonrandomized observational studies can be misleading, and rational conjecture has led to many mistakes in medicine,” he said. “Be willing to challenge conventional wisdom.”
For example, the standard of care in the 1970s, based on two nonrandomized retrospective reviews of 175 babies, included orapharyngeal and nasopharyngeal suction by the obstetrician and endotracheal tube (ETT) suction by the pediatrician. In the 2000s, however, an RCT of 2,500 infants found no benefit from orapharyngeal and nasopharyngeal suction, even with thick MSAF, (Lancet. 2004 Aug 14-20;364[9434]:597-602) and another RCT with 2,100 infants found no benefit from ETT suction (Pediatrics. 2000 Jan;105[1 Pt 1]:1-7).
More recent, smaller studies have confirmed those conclusions and found similar lack of benefit from ETT in non-vigorous infants, contributing to the new recommendation (Resuscitation. 2016 Aug;105:79-84; Indian J Pediatr. 2016 Oct;83[10]:1125-30).
“Routine tracheal suction is no longer recommended for nonvigorous babies with meconium stained fluid,” Dr. Weiner said. Since MSAF is risk factor for resuscitation, though, at least two clinicians with Neonatal Resuscitation Program (NRP) training should be present, as well as a full team if resuscitation is expected.
Heart rate assessment and tracking
“The baby’s heart rate needs to be monitored during PPV [positive pressure ventilation] because a prompt increase in the baby’s heart rate is the most important indicator of effective PPV,” Dr. Weiner said in an interview. “Half of errors made during NRP [Neonatal Resuscitation Program] simulations are the result of incorrect heart rate assessment.”
Recent evidence comparing pulse oximetry to an EC monitor favored the latter for tracking heart rate, leading to the other new recommendation.
“The baby’s heart rate can be monitored using the pulse oximeter,” Dr. Weiner said. “However, health providers should consider using an electronic cardiac monitor in addition to pulse oximetry because studies show that it achieves a reliable signal faster.” He cited a study of 20 newborns that showed an EC monitor determined the heart rate in a median 34 seconds, compared with 122 seconds with the pulse oximeter (Pediatr Int. 2012 Apr;54[2]:205-7).
Pulse oximetry takes 90-120 seconds to attain a reliable signal and may not work if there’s poor perfusion, but an EC monitor provides continuous heart rate monitoring even with poor perfusion. So an initial heart rate assessment by auscultation is fine, but if PPV begins, EC monitoring may be better and is the preferred method with anticipated resuscitation or chest compressions.
However, pulse oximetry is still recommended “whenever positive pressure ventilation is started or oxygen is administered in order to guide the appropriate amount of oxygen supplementation,” Dr. Weiner noted.
He added that “preliminary studies suggest that handheld Doppler fetal heart monitors correlate well with ECG, provide a rapid audible heart rate and may be a promising alternative in the future” (Pediatr Int. 2017 Oct;59[10]:1069-73).
Correct ventilation techniques
“Ventilation of the lungs is the single most important and most effective step in cardiopulmonary resuscitation of the compromised newborn,” Dr. Weiner said. “If the heart rate is not rapidly increasing, ask if the chest is moving.”
He emphasized that no compressions should occur until after at least 30 seconds of PPV that moves the chest. He provided a “MR. SOPA” acronym: Mask adjustment, Reposition airway, Suction, Open mouth, Pressure increase, Alternative airway.
You also should be aware of possible leaking or obstruction around the mask, which is common, he said, so monitor pressure instead of volume.
“We are not good at identifying leak, obstruction, or adequate tidal volume,” Dr. Weiner said. “A colorimetric CO2 detector attached to the mask is a simple indicator of gas exchange” (Resuscitation. 2014 Nov;85[11]:1568-72).
He also strongly recommended inserting an alternative airway before starting chest compressions with either intubation or a laryngeal mask.
Dr. Weiner concluded with the following list of clinical practice changes you may consider:
- Use a standardized equipment checklist.
- Develop and practice standardized scripts.
- Debrief after all resuscitations; use videotape if you can.
- Delay cord clamping for most term and preterm babies.
- Do not routinely intubate/suction nonvigorous newborns with MSAF. Initiate resuscitation.
- Use an electronic cardiac monitor if resuscitation is required.
- Use a colorimetric CO2 detector with PPV.
- Intubate or place a laryngeal mask before starting compressions.
Dr. Weiner reported having no disclosures, and no external funding was used for the presentation.
EXPERT ANALYSIS FROM AAP 2017
Chinese school-based flu vaccination program reduced outbreaks
, said Yang Pan, PhD, of the Institute for Infectious Disease and Endemic Disease Control, Beijing Center for Disease Prevention and Control, and associates.
School-based trivalent inactivated influenza vaccination programs generally occurred Oct. 15-Nov. 30 each year since 2007, with greater than 50% vaccination coverage. In an 11-year retrospective study of school outbreaks of influenza in elementary, middle, and high schools in the Beijing area during Sept. 1, 2006-March 31, 2017, there were 286 febrile outbreaks in schools, involving 6,863 children.
During the 11 years, a mismatch between circulating strains and vaccine strains was identified in two influenza seasons, such as “the A(H3N2) 3C.1 (vaccine strain)-A(H3N2) 3C.3a (circulating strains) mismatch in 2014-2015, the B(Yamagata) Clade 2 (vaccine strain)-B(Yamagata) Clade 3 (circulating strain) mismatch in the 2014-2015 influenza season, and B(Yamagata) (vaccine strain)-B(Victoria) (circulating strains) mismatch in 2015-2016,” they reported.
A combination of high flu vaccine coverage because of school-based vaccinations and a good vaccine match reduced influenza outbreaks in schools by 89% (odds ratio, 0.111), Dr. Pan and associates concluded.
“The school-based influenza vaccination program has been in operation for nearly 10 years in the Beijing area, is unique in China, and is one of the few school-based influenza programs in the world,” the researchers explained. “These data can inform and improve vaccination policy locally and nationally.”
Read more in Vaccine (2017 Nov 8. doi: 10.1016/j.vaccine.2017.10.096).
, said Yang Pan, PhD, of the Institute for Infectious Disease and Endemic Disease Control, Beijing Center for Disease Prevention and Control, and associates.
School-based trivalent inactivated influenza vaccination programs generally occurred Oct. 15-Nov. 30 each year since 2007, with greater than 50% vaccination coverage. In an 11-year retrospective study of school outbreaks of influenza in elementary, middle, and high schools in the Beijing area during Sept. 1, 2006-March 31, 2017, there were 286 febrile outbreaks in schools, involving 6,863 children.
During the 11 years, a mismatch between circulating strains and vaccine strains was identified in two influenza seasons, such as “the A(H3N2) 3C.1 (vaccine strain)-A(H3N2) 3C.3a (circulating strains) mismatch in 2014-2015, the B(Yamagata) Clade 2 (vaccine strain)-B(Yamagata) Clade 3 (circulating strain) mismatch in the 2014-2015 influenza season, and B(Yamagata) (vaccine strain)-B(Victoria) (circulating strains) mismatch in 2015-2016,” they reported.
A combination of high flu vaccine coverage because of school-based vaccinations and a good vaccine match reduced influenza outbreaks in schools by 89% (odds ratio, 0.111), Dr. Pan and associates concluded.
“The school-based influenza vaccination program has been in operation for nearly 10 years in the Beijing area, is unique in China, and is one of the few school-based influenza programs in the world,” the researchers explained. “These data can inform and improve vaccination policy locally and nationally.”
Read more in Vaccine (2017 Nov 8. doi: 10.1016/j.vaccine.2017.10.096).
, said Yang Pan, PhD, of the Institute for Infectious Disease and Endemic Disease Control, Beijing Center for Disease Prevention and Control, and associates.
School-based trivalent inactivated influenza vaccination programs generally occurred Oct. 15-Nov. 30 each year since 2007, with greater than 50% vaccination coverage. In an 11-year retrospective study of school outbreaks of influenza in elementary, middle, and high schools in the Beijing area during Sept. 1, 2006-March 31, 2017, there were 286 febrile outbreaks in schools, involving 6,863 children.
During the 11 years, a mismatch between circulating strains and vaccine strains was identified in two influenza seasons, such as “the A(H3N2) 3C.1 (vaccine strain)-A(H3N2) 3C.3a (circulating strains) mismatch in 2014-2015, the B(Yamagata) Clade 2 (vaccine strain)-B(Yamagata) Clade 3 (circulating strain) mismatch in the 2014-2015 influenza season, and B(Yamagata) (vaccine strain)-B(Victoria) (circulating strains) mismatch in 2015-2016,” they reported.
A combination of high flu vaccine coverage because of school-based vaccinations and a good vaccine match reduced influenza outbreaks in schools by 89% (odds ratio, 0.111), Dr. Pan and associates concluded.
“The school-based influenza vaccination program has been in operation for nearly 10 years in the Beijing area, is unique in China, and is one of the few school-based influenza programs in the world,” the researchers explained. “These data can inform and improve vaccination policy locally and nationally.”
Read more in Vaccine (2017 Nov 8. doi: 10.1016/j.vaccine.2017.10.096).
FROM VACCINE
Systems biology – A primer
Systems biology is relatively new. It is an interdisciplinary field that focuses on complex interactions within biological systems using a holistic approach in the pursuit of scientific discovery.
The systems biology approach seeks to integrate biological knowledge to understand how cells and molecules interact with one another. A key component is computational and mathematical modeling. The ever-increasing amount of biological data, and the judgment that this data cannot be understood by simply drawing lines between interacting cells and molecules, explains the demand for a systematic approach.
Prominent examples for biological systems are the immune system and the nervous system, which already have the word ”system” included. Although the idea of system-level understanding is not new, the growing interest in applying the systems approach has been driven by breakthrough advances in molecular biology and bioinformatics.
Over the past 10 years, our group has identified highly significant differences in immune functioning between the 10% of children who frequently develop acute otitis media (i.e., those who are “otitis prone”) and the children who develop AOM infrequently (60% of children) or not at all (30% of children). We also have identified a cohort of about 10% of children who fail to respond to infant vaccinations (low vaccine responders), compared with children who respond with protective immunity and establishment of immune memory. The differences in children who are prone to AOM vs. those who are not and in low vaccine responders vs. normal vaccine responders include differences in cytokine molecules in blood (providing biosignatures), reduced antibodies, immune memory, and aberrant intercellular signaling networks after otopathogen exposure (AOM prone vs. non–AOM prone) and routine pediatric vaccination (low vs. normal vaccine responders).
Dr. Pichichero, a specialist in pediatric infectious diseases, is director of the Research Institute at Rochester (N.Y.) General Hospital. He is also a pediatrician at Legacy Pediatrics in Rochester. He has no relevant financial disclosures. Email him at pdnews@frontlinemedcom.com.
Systems biology is relatively new. It is an interdisciplinary field that focuses on complex interactions within biological systems using a holistic approach in the pursuit of scientific discovery.
The systems biology approach seeks to integrate biological knowledge to understand how cells and molecules interact with one another. A key component is computational and mathematical modeling. The ever-increasing amount of biological data, and the judgment that this data cannot be understood by simply drawing lines between interacting cells and molecules, explains the demand for a systematic approach.
Prominent examples for biological systems are the immune system and the nervous system, which already have the word ”system” included. Although the idea of system-level understanding is not new, the growing interest in applying the systems approach has been driven by breakthrough advances in molecular biology and bioinformatics.
Over the past 10 years, our group has identified highly significant differences in immune functioning between the 10% of children who frequently develop acute otitis media (i.e., those who are “otitis prone”) and the children who develop AOM infrequently (60% of children) or not at all (30% of children). We also have identified a cohort of about 10% of children who fail to respond to infant vaccinations (low vaccine responders), compared with children who respond with protective immunity and establishment of immune memory. The differences in children who are prone to AOM vs. those who are not and in low vaccine responders vs. normal vaccine responders include differences in cytokine molecules in blood (providing biosignatures), reduced antibodies, immune memory, and aberrant intercellular signaling networks after otopathogen exposure (AOM prone vs. non–AOM prone) and routine pediatric vaccination (low vs. normal vaccine responders).
Dr. Pichichero, a specialist in pediatric infectious diseases, is director of the Research Institute at Rochester (N.Y.) General Hospital. He is also a pediatrician at Legacy Pediatrics in Rochester. He has no relevant financial disclosures. Email him at pdnews@frontlinemedcom.com.
Systems biology is relatively new. It is an interdisciplinary field that focuses on complex interactions within biological systems using a holistic approach in the pursuit of scientific discovery.
The systems biology approach seeks to integrate biological knowledge to understand how cells and molecules interact with one another. A key component is computational and mathematical modeling. The ever-increasing amount of biological data, and the judgment that this data cannot be understood by simply drawing lines between interacting cells and molecules, explains the demand for a systematic approach.
Prominent examples for biological systems are the immune system and the nervous system, which already have the word ”system” included. Although the idea of system-level understanding is not new, the growing interest in applying the systems approach has been driven by breakthrough advances in molecular biology and bioinformatics.
Over the past 10 years, our group has identified highly significant differences in immune functioning between the 10% of children who frequently develop acute otitis media (i.e., those who are “otitis prone”) and the children who develop AOM infrequently (60% of children) or not at all (30% of children). We also have identified a cohort of about 10% of children who fail to respond to infant vaccinations (low vaccine responders), compared with children who respond with protective immunity and establishment of immune memory. The differences in children who are prone to AOM vs. those who are not and in low vaccine responders vs. normal vaccine responders include differences in cytokine molecules in blood (providing biosignatures), reduced antibodies, immune memory, and aberrant intercellular signaling networks after otopathogen exposure (AOM prone vs. non–AOM prone) and routine pediatric vaccination (low vs. normal vaccine responders).
Dr. Pichichero, a specialist in pediatric infectious diseases, is director of the Research Institute at Rochester (N.Y.) General Hospital. He is also a pediatrician at Legacy Pediatrics in Rochester. He has no relevant financial disclosures. Email him at pdnews@frontlinemedcom.com.
MMR vaccine coverage at 94% in kindergartners
, according to the Centers for Disease Control and Prevention.
A look at the map shows that state coverage of required MMR doses varied considerably. Mississippi (99.4%), Maryland (99.3%), Delaware (98.5%), California (97.3%), New York (97.3%), Texas (97.3%), and Louisiana (97.1%) were the furthest above the national median. Occupying the low end of the range were the District of Columbia (85.6%), Colorado (87.3%), Indiana (88.9%), Alaska (89.0%), Kansas (89.5%), and Idaho (89.9%), reported Ranee Seither, MPH, of the National Center for Immunization and Respiratory Disease, and associates at the CDC, Atlanta (MMWR 2017 Oct 13;66[40]:1073-80).
The data for the CDC analysis, which included 3,973,172 kindergartners for the 2016-2017 school year, were collected by federally funded immunization programs in the 50 states and D.C.
, according to the Centers for Disease Control and Prevention.
A look at the map shows that state coverage of required MMR doses varied considerably. Mississippi (99.4%), Maryland (99.3%), Delaware (98.5%), California (97.3%), New York (97.3%), Texas (97.3%), and Louisiana (97.1%) were the furthest above the national median. Occupying the low end of the range were the District of Columbia (85.6%), Colorado (87.3%), Indiana (88.9%), Alaska (89.0%), Kansas (89.5%), and Idaho (89.9%), reported Ranee Seither, MPH, of the National Center for Immunization and Respiratory Disease, and associates at the CDC, Atlanta (MMWR 2017 Oct 13;66[40]:1073-80).
The data for the CDC analysis, which included 3,973,172 kindergartners for the 2016-2017 school year, were collected by federally funded immunization programs in the 50 states and D.C.
, according to the Centers for Disease Control and Prevention.
A look at the map shows that state coverage of required MMR doses varied considerably. Mississippi (99.4%), Maryland (99.3%), Delaware (98.5%), California (97.3%), New York (97.3%), Texas (97.3%), and Louisiana (97.1%) were the furthest above the national median. Occupying the low end of the range were the District of Columbia (85.6%), Colorado (87.3%), Indiana (88.9%), Alaska (89.0%), Kansas (89.5%), and Idaho (89.9%), reported Ranee Seither, MPH, of the National Center for Immunization and Respiratory Disease, and associates at the CDC, Atlanta (MMWR 2017 Oct 13;66[40]:1073-80).
The data for the CDC analysis, which included 3,973,172 kindergartners for the 2016-2017 school year, were collected by federally funded immunization programs in the 50 states and D.C.
FROM MMWR
Benralizumab approved for eosinophilic asthma
This is the only respiratory biologic to provide fast and “near-complete depletion of eosinophils within 24 hours,” according to the statement from AstraZeneca.
Similar adverse events were seen in patients who took benralizumab and the placebo. AstraZeneca will market benralizumab under the trade name Fasenra.
“This is an important day for severe, eosinophilic asthma patients who have had limited treatment options for far too long,” said Eugene Bleecker, MD, professor and codirector of genetics, genomics, and precision medicine at the University of Arizona in Tucson, in the statement.
This is the only respiratory biologic to provide fast and “near-complete depletion of eosinophils within 24 hours,” according to the statement from AstraZeneca.
Similar adverse events were seen in patients who took benralizumab and the placebo. AstraZeneca will market benralizumab under the trade name Fasenra.
“This is an important day for severe, eosinophilic asthma patients who have had limited treatment options for far too long,” said Eugene Bleecker, MD, professor and codirector of genetics, genomics, and precision medicine at the University of Arizona in Tucson, in the statement.
This is the only respiratory biologic to provide fast and “near-complete depletion of eosinophils within 24 hours,” according to the statement from AstraZeneca.
Similar adverse events were seen in patients who took benralizumab and the placebo. AstraZeneca will market benralizumab under the trade name Fasenra.
“This is an important day for severe, eosinophilic asthma patients who have had limited treatment options for far too long,” said Eugene Bleecker, MD, professor and codirector of genetics, genomics, and precision medicine at the University of Arizona in Tucson, in the statement.