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Non-cow’s milk associated with lower childhood height
SAN FRANCISCO – Consumption of non-cow’s milk in early childhood is associated with decreased height, compared with consumption of cow’s milk by children in the same stage of life, a study has shown. The results call into question perceived health benefits of the consumption of non-cow’s milk in childhood.
“These findings are important for health care workers and parents in terms of optimal growth of children and the kind of milk needed to achieve that,” presenter Marie-Elssa Morency explained at the meeting of the Pediatric Academic Societies. Ms. Morency is a master’s student in the department of nutritional sciences at the University of Toronto.
Whether cow’s milk is a better source than non-cow’s milk of nutritional and caloric energy to a growing body has not been studied with rigor. Perceived health benefits of non-cow’s milk have led some parents to substitute cow’s milk with other types of milk for their children, Ms. Morency said.
To gain some clarity, the researchers looked at data from the TARGetKids! longitudinal cohort of children. The cohort is being followed into adolescence to link early life exposures to various physiological and developmental health problems. The present study looked at more than 5,000 healthy children aged 24-72 months. Any conditions that could affect growth were grounds for exclusion.
The primary exposure was the daily consumption of cow’s milk in 4,632 children or non-cow’s milk in 643 children. The typical number of 250-mL glasses of milk consumed per day was gleaned by a questionnaire completed by the parents. The primary outcome was height-for-age z score.
The two groups were similar at baseline in age, sex (slightly more than half were male), body mass index, and maternal height. Those who predominantly consumed cow’s milk averaged 2 cups per day. Some also consumed non-cow’s milk (about one glass per day). Those in the non-cow’s milk group consumed on average 1.4 cups per day, with cow’s milk consumption being rare.
The overall z-score was 0.1 (95% confidence interval [CI], –0.6 to 0.8). The groups differed in z-score, with a score of 0.2 (95% CI, –0.6 to 0.8) in the cow’s milk group and –0.04 (95% CI, –0.8 to 0.7) in the non-cow’s milk group. The resulting shorter height in those consuming non-cow’s milk was 0.42 cm (95% CI, –0.61 to –0.19) in a univariate analysis (P less than .001). A multivariate analysis that adjusted for age, sex, maternal ethnicity, maternal height, z-score, and neighborhood income revealed a significant difference in the same group of 0.31 cm (95% CI, –0.50 to –0.11; P less than .001).
The reduced consumption of cow’s milk in the non-cow’s milk group was identified as a partial mediator of the association between non-cow’s milk consumption and height. Putting the results into context, Ms. Morency explained that a 3-year-old child typically drinking 3 cups of non-cow’s milk each day (about twice the average in this study) would be 1.5 cm shorter than a similar child drinking the same amount of cow’s milk each day.
The literature shows that height children achieve during childhood is an important benchmark of growth and development, adequate nutrition, and pending obesity. Shorter-than average children can often be shorter than average in height as adults, which has been linked with increased risk of type 2 diabetes, gestational diabetes, coronary heart disease, and hypertension.
Diet influences height: Reduced calories and nutrients in an inadequate diet hinder growth, Ms. Morency noted. Cow’s milk delivers more protein, fat, vitamins, minerals, and calories than do non-cow’s milk formulations, such as almond milk and soy milk, she said.
“While non-cow’s milk consumption in childhood may have other health benefits, increased height does not appear to be one of them,” said Ms. Morency.
Study strengths include the relatively large sample size, statistical rigor, and consistent findings with prior studies. Limitations include the cross-sectional design that rules out any conclusions about direct cause, and the use of questionnaire data, which inherently comes with problems of report and recall bias.
A causal connection awaits randomized controlled trials.
The University of Toronto sponsored the study, which was funded by the Canadian Institutes for Health Research. Ms. Morency reported having no financial disclosures.
SAN FRANCISCO – Consumption of non-cow’s milk in early childhood is associated with decreased height, compared with consumption of cow’s milk by children in the same stage of life, a study has shown. The results call into question perceived health benefits of the consumption of non-cow’s milk in childhood.
“These findings are important for health care workers and parents in terms of optimal growth of children and the kind of milk needed to achieve that,” presenter Marie-Elssa Morency explained at the meeting of the Pediatric Academic Societies. Ms. Morency is a master’s student in the department of nutritional sciences at the University of Toronto.
Whether cow’s milk is a better source than non-cow’s milk of nutritional and caloric energy to a growing body has not been studied with rigor. Perceived health benefits of non-cow’s milk have led some parents to substitute cow’s milk with other types of milk for their children, Ms. Morency said.
To gain some clarity, the researchers looked at data from the TARGetKids! longitudinal cohort of children. The cohort is being followed into adolescence to link early life exposures to various physiological and developmental health problems. The present study looked at more than 5,000 healthy children aged 24-72 months. Any conditions that could affect growth were grounds for exclusion.
The primary exposure was the daily consumption of cow’s milk in 4,632 children or non-cow’s milk in 643 children. The typical number of 250-mL glasses of milk consumed per day was gleaned by a questionnaire completed by the parents. The primary outcome was height-for-age z score.
The two groups were similar at baseline in age, sex (slightly more than half were male), body mass index, and maternal height. Those who predominantly consumed cow’s milk averaged 2 cups per day. Some also consumed non-cow’s milk (about one glass per day). Those in the non-cow’s milk group consumed on average 1.4 cups per day, with cow’s milk consumption being rare.
The overall z-score was 0.1 (95% confidence interval [CI], –0.6 to 0.8). The groups differed in z-score, with a score of 0.2 (95% CI, –0.6 to 0.8) in the cow’s milk group and –0.04 (95% CI, –0.8 to 0.7) in the non-cow’s milk group. The resulting shorter height in those consuming non-cow’s milk was 0.42 cm (95% CI, –0.61 to –0.19) in a univariate analysis (P less than .001). A multivariate analysis that adjusted for age, sex, maternal ethnicity, maternal height, z-score, and neighborhood income revealed a significant difference in the same group of 0.31 cm (95% CI, –0.50 to –0.11; P less than .001).
The reduced consumption of cow’s milk in the non-cow’s milk group was identified as a partial mediator of the association between non-cow’s milk consumption and height. Putting the results into context, Ms. Morency explained that a 3-year-old child typically drinking 3 cups of non-cow’s milk each day (about twice the average in this study) would be 1.5 cm shorter than a similar child drinking the same amount of cow’s milk each day.
The literature shows that height children achieve during childhood is an important benchmark of growth and development, adequate nutrition, and pending obesity. Shorter-than average children can often be shorter than average in height as adults, which has been linked with increased risk of type 2 diabetes, gestational diabetes, coronary heart disease, and hypertension.
Diet influences height: Reduced calories and nutrients in an inadequate diet hinder growth, Ms. Morency noted. Cow’s milk delivers more protein, fat, vitamins, minerals, and calories than do non-cow’s milk formulations, such as almond milk and soy milk, she said.
“While non-cow’s milk consumption in childhood may have other health benefits, increased height does not appear to be one of them,” said Ms. Morency.
Study strengths include the relatively large sample size, statistical rigor, and consistent findings with prior studies. Limitations include the cross-sectional design that rules out any conclusions about direct cause, and the use of questionnaire data, which inherently comes with problems of report and recall bias.
A causal connection awaits randomized controlled trials.
The University of Toronto sponsored the study, which was funded by the Canadian Institutes for Health Research. Ms. Morency reported having no financial disclosures.
SAN FRANCISCO – Consumption of non-cow’s milk in early childhood is associated with decreased height, compared with consumption of cow’s milk by children in the same stage of life, a study has shown. The results call into question perceived health benefits of the consumption of non-cow’s milk in childhood.
“These findings are important for health care workers and parents in terms of optimal growth of children and the kind of milk needed to achieve that,” presenter Marie-Elssa Morency explained at the meeting of the Pediatric Academic Societies. Ms. Morency is a master’s student in the department of nutritional sciences at the University of Toronto.
Whether cow’s milk is a better source than non-cow’s milk of nutritional and caloric energy to a growing body has not been studied with rigor. Perceived health benefits of non-cow’s milk have led some parents to substitute cow’s milk with other types of milk for their children, Ms. Morency said.
To gain some clarity, the researchers looked at data from the TARGetKids! longitudinal cohort of children. The cohort is being followed into adolescence to link early life exposures to various physiological and developmental health problems. The present study looked at more than 5,000 healthy children aged 24-72 months. Any conditions that could affect growth were grounds for exclusion.
The primary exposure was the daily consumption of cow’s milk in 4,632 children or non-cow’s milk in 643 children. The typical number of 250-mL glasses of milk consumed per day was gleaned by a questionnaire completed by the parents. The primary outcome was height-for-age z score.
The two groups were similar at baseline in age, sex (slightly more than half were male), body mass index, and maternal height. Those who predominantly consumed cow’s milk averaged 2 cups per day. Some also consumed non-cow’s milk (about one glass per day). Those in the non-cow’s milk group consumed on average 1.4 cups per day, with cow’s milk consumption being rare.
The overall z-score was 0.1 (95% confidence interval [CI], –0.6 to 0.8). The groups differed in z-score, with a score of 0.2 (95% CI, –0.6 to 0.8) in the cow’s milk group and –0.04 (95% CI, –0.8 to 0.7) in the non-cow’s milk group. The resulting shorter height in those consuming non-cow’s milk was 0.42 cm (95% CI, –0.61 to –0.19) in a univariate analysis (P less than .001). A multivariate analysis that adjusted for age, sex, maternal ethnicity, maternal height, z-score, and neighborhood income revealed a significant difference in the same group of 0.31 cm (95% CI, –0.50 to –0.11; P less than .001).
The reduced consumption of cow’s milk in the non-cow’s milk group was identified as a partial mediator of the association between non-cow’s milk consumption and height. Putting the results into context, Ms. Morency explained that a 3-year-old child typically drinking 3 cups of non-cow’s milk each day (about twice the average in this study) would be 1.5 cm shorter than a similar child drinking the same amount of cow’s milk each day.
The literature shows that height children achieve during childhood is an important benchmark of growth and development, adequate nutrition, and pending obesity. Shorter-than average children can often be shorter than average in height as adults, which has been linked with increased risk of type 2 diabetes, gestational diabetes, coronary heart disease, and hypertension.
Diet influences height: Reduced calories and nutrients in an inadequate diet hinder growth, Ms. Morency noted. Cow’s milk delivers more protein, fat, vitamins, minerals, and calories than do non-cow’s milk formulations, such as almond milk and soy milk, she said.
“While non-cow’s milk consumption in childhood may have other health benefits, increased height does not appear to be one of them,” said Ms. Morency.
Study strengths include the relatively large sample size, statistical rigor, and consistent findings with prior studies. Limitations include the cross-sectional design that rules out any conclusions about direct cause, and the use of questionnaire data, which inherently comes with problems of report and recall bias.
A causal connection awaits randomized controlled trials.
The University of Toronto sponsored the study, which was funded by the Canadian Institutes for Health Research. Ms. Morency reported having no financial disclosures.
Novel evaluation, treatment of NAS decreases medication use
AT PAS 2017
SAN FRANCISCO – A nonpharmacologic approach to neonatal abstinence syndrome (NAS) appears to reduce the use of morphine and may shorten hospital stay, compared with the conventional evaluation that looks at symptoms of opioid withdrawal, a study showed.
“If you focus on the well-being of these infants rather than a list of symptoms, you are much less likely to start medication. Our approach inherently destigmatizes the parents of these infants by allowing them to focus on the same things that any other parent focuses on,” said Matthew Lipshaw, MD, a pediatrician at Yale–New Haven (Conn.) Children’s Hospital.
The novel approach aims instead to avoid drug use. According to Dr. Lipshaw, the nonintrusive approach “assesses infants’ ability to function as infants during their withdrawal.” The approach provides a low-stimulation environment featuring rooming-in by mothers, and frequent feeding of their infants. Dubbed ESC, the approach gauges the ability of an infant to eat 1 ounce or more or breastfeed well, sleep undisturbed for an hour or longer, and be consolable within 10 minutes.
The ESC approach replaced the FNASS at Yale–New Haven Children’s Hospital in 2013. While patient management decisions since then have been based on ESC, FNASS scores have continued to be collected every 2-6 hours. This provided the researchers with the means to conduct a head-to-head comparison of the two systems on the same patients.
The records of 50 consecutive newborns born from March 2014 to August 2015 who had been exposed to opioids for at least 30 days prior to birth were reviewed. The primary outcome was the proportion of infants treated with morphine. Secondary outcomes included disagreements between the two approaches on a daily basis, seizures, 30-day readmissions, and need for more intensive care.
The neonates (56%, female) were mostly white. All were born at greater than 36 weeks’ gestation. Opioid exposure was methadone in 80% of cases and buprenorphine in 14%, with the remaining 6% exposed to hydrocodone, Percocet (acetaminophen/oxycodone), and/or OxyContin (oxycodone).
Morphine was started in 6 (12%) of the 50 patients. If the FNASS protocol had been followed, 31 (62%) of the infants would have been started on morphine (P less than .01). Over a span of 296 hospital days, when the ESC protocol was used, morphine was not used 87% of the time, morphine use was increased 3% of the time, use was decreased 7% of the time, and use was maintained 3% of the time. If decisions had been made based on the FNASS protocol, the frequency of nonuse, increased use, decreased use, and maintained use of morphine would have been 53%, 26%, 12%, and 10%, respectively (all P less than .01).
The use of morphine was less than the FNASS recommendation on 78 days (26% of the total days). Moreover, the FNASS scores on the days following the decreased use of morphine were lower by an average of 0.9 points and were decreased in 69% of cases. The ESC protocol led to greater morphine use than recommended by the FNASS protocol on only 2 days. Both times, the FNASS score was increased the following day.
No adverse events occurred during the study.
“These findings are significant because nearly all institutions use the Finnegan score to guide management, and most research has used Finnegan-based medication thresholds to evaluate new medical therapies. Our point is that if you base your assessment on function, many of these infants may not need medication at all. We have had dramatic reductions in length of stay, which allows these infants to get home and minimize the interruption in this crucial period for maternal-child bonding in these high-risk patients,” Dr. Lipshaw said at the Pediatric Academic Societies meeting.
So far, only the Boston Medical Center has implemented the new system. This does not surprise Dr. Lipshaw: “Most places have been using a symptom-based approach for decades. It requires major buy in from physicians and nurses who have been doing things differently for a long time.”
He said is not deterred, however, and pointed to ongoing efforts by colleagues at Yale–New Haven Hospital and Boston Medical Center that are underway that could led to the ESC’s use in a network of hospitals in New Hampshire and Vermont.
The study was sponsored by Yale–New Haven Children’s Hospital and was not funded. Dr. Lipshaw reported having no relevant financial disclosures.
AT PAS 2017
SAN FRANCISCO – A nonpharmacologic approach to neonatal abstinence syndrome (NAS) appears to reduce the use of morphine and may shorten hospital stay, compared with the conventional evaluation that looks at symptoms of opioid withdrawal, a study showed.
“If you focus on the well-being of these infants rather than a list of symptoms, you are much less likely to start medication. Our approach inherently destigmatizes the parents of these infants by allowing them to focus on the same things that any other parent focuses on,” said Matthew Lipshaw, MD, a pediatrician at Yale–New Haven (Conn.) Children’s Hospital.
The novel approach aims instead to avoid drug use. According to Dr. Lipshaw, the nonintrusive approach “assesses infants’ ability to function as infants during their withdrawal.” The approach provides a low-stimulation environment featuring rooming-in by mothers, and frequent feeding of their infants. Dubbed ESC, the approach gauges the ability of an infant to eat 1 ounce or more or breastfeed well, sleep undisturbed for an hour or longer, and be consolable within 10 minutes.
The ESC approach replaced the FNASS at Yale–New Haven Children’s Hospital in 2013. While patient management decisions since then have been based on ESC, FNASS scores have continued to be collected every 2-6 hours. This provided the researchers with the means to conduct a head-to-head comparison of the two systems on the same patients.
The records of 50 consecutive newborns born from March 2014 to August 2015 who had been exposed to opioids for at least 30 days prior to birth were reviewed. The primary outcome was the proportion of infants treated with morphine. Secondary outcomes included disagreements between the two approaches on a daily basis, seizures, 30-day readmissions, and need for more intensive care.
The neonates (56%, female) were mostly white. All were born at greater than 36 weeks’ gestation. Opioid exposure was methadone in 80% of cases and buprenorphine in 14%, with the remaining 6% exposed to hydrocodone, Percocet (acetaminophen/oxycodone), and/or OxyContin (oxycodone).
Morphine was started in 6 (12%) of the 50 patients. If the FNASS protocol had been followed, 31 (62%) of the infants would have been started on morphine (P less than .01). Over a span of 296 hospital days, when the ESC protocol was used, morphine was not used 87% of the time, morphine use was increased 3% of the time, use was decreased 7% of the time, and use was maintained 3% of the time. If decisions had been made based on the FNASS protocol, the frequency of nonuse, increased use, decreased use, and maintained use of morphine would have been 53%, 26%, 12%, and 10%, respectively (all P less than .01).
The use of morphine was less than the FNASS recommendation on 78 days (26% of the total days). Moreover, the FNASS scores on the days following the decreased use of morphine were lower by an average of 0.9 points and were decreased in 69% of cases. The ESC protocol led to greater morphine use than recommended by the FNASS protocol on only 2 days. Both times, the FNASS score was increased the following day.
No adverse events occurred during the study.
“These findings are significant because nearly all institutions use the Finnegan score to guide management, and most research has used Finnegan-based medication thresholds to evaluate new medical therapies. Our point is that if you base your assessment on function, many of these infants may not need medication at all. We have had dramatic reductions in length of stay, which allows these infants to get home and minimize the interruption in this crucial period for maternal-child bonding in these high-risk patients,” Dr. Lipshaw said at the Pediatric Academic Societies meeting.
So far, only the Boston Medical Center has implemented the new system. This does not surprise Dr. Lipshaw: “Most places have been using a symptom-based approach for decades. It requires major buy in from physicians and nurses who have been doing things differently for a long time.”
He said is not deterred, however, and pointed to ongoing efforts by colleagues at Yale–New Haven Hospital and Boston Medical Center that are underway that could led to the ESC’s use in a network of hospitals in New Hampshire and Vermont.
The study was sponsored by Yale–New Haven Children’s Hospital and was not funded. Dr. Lipshaw reported having no relevant financial disclosures.
AT PAS 2017
SAN FRANCISCO – A nonpharmacologic approach to neonatal abstinence syndrome (NAS) appears to reduce the use of morphine and may shorten hospital stay, compared with the conventional evaluation that looks at symptoms of opioid withdrawal, a study showed.
“If you focus on the well-being of these infants rather than a list of symptoms, you are much less likely to start medication. Our approach inherently destigmatizes the parents of these infants by allowing them to focus on the same things that any other parent focuses on,” said Matthew Lipshaw, MD, a pediatrician at Yale–New Haven (Conn.) Children’s Hospital.
The novel approach aims instead to avoid drug use. According to Dr. Lipshaw, the nonintrusive approach “assesses infants’ ability to function as infants during their withdrawal.” The approach provides a low-stimulation environment featuring rooming-in by mothers, and frequent feeding of their infants. Dubbed ESC, the approach gauges the ability of an infant to eat 1 ounce or more or breastfeed well, sleep undisturbed for an hour or longer, and be consolable within 10 minutes.
The ESC approach replaced the FNASS at Yale–New Haven Children’s Hospital in 2013. While patient management decisions since then have been based on ESC, FNASS scores have continued to be collected every 2-6 hours. This provided the researchers with the means to conduct a head-to-head comparison of the two systems on the same patients.
The records of 50 consecutive newborns born from March 2014 to August 2015 who had been exposed to opioids for at least 30 days prior to birth were reviewed. The primary outcome was the proportion of infants treated with morphine. Secondary outcomes included disagreements between the two approaches on a daily basis, seizures, 30-day readmissions, and need for more intensive care.
The neonates (56%, female) were mostly white. All were born at greater than 36 weeks’ gestation. Opioid exposure was methadone in 80% of cases and buprenorphine in 14%, with the remaining 6% exposed to hydrocodone, Percocet (acetaminophen/oxycodone), and/or OxyContin (oxycodone).
Morphine was started in 6 (12%) of the 50 patients. If the FNASS protocol had been followed, 31 (62%) of the infants would have been started on morphine (P less than .01). Over a span of 296 hospital days, when the ESC protocol was used, morphine was not used 87% of the time, morphine use was increased 3% of the time, use was decreased 7% of the time, and use was maintained 3% of the time. If decisions had been made based on the FNASS protocol, the frequency of nonuse, increased use, decreased use, and maintained use of morphine would have been 53%, 26%, 12%, and 10%, respectively (all P less than .01).
The use of morphine was less than the FNASS recommendation on 78 days (26% of the total days). Moreover, the FNASS scores on the days following the decreased use of morphine were lower by an average of 0.9 points and were decreased in 69% of cases. The ESC protocol led to greater morphine use than recommended by the FNASS protocol on only 2 days. Both times, the FNASS score was increased the following day.
No adverse events occurred during the study.
“These findings are significant because nearly all institutions use the Finnegan score to guide management, and most research has used Finnegan-based medication thresholds to evaluate new medical therapies. Our point is that if you base your assessment on function, many of these infants may not need medication at all. We have had dramatic reductions in length of stay, which allows these infants to get home and minimize the interruption in this crucial period for maternal-child bonding in these high-risk patients,” Dr. Lipshaw said at the Pediatric Academic Societies meeting.
So far, only the Boston Medical Center has implemented the new system. This does not surprise Dr. Lipshaw: “Most places have been using a symptom-based approach for decades. It requires major buy in from physicians and nurses who have been doing things differently for a long time.”
He said is not deterred, however, and pointed to ongoing efforts by colleagues at Yale–New Haven Hospital and Boston Medical Center that are underway that could led to the ESC’s use in a network of hospitals in New Hampshire and Vermont.
The study was sponsored by Yale–New Haven Children’s Hospital and was not funded. Dr. Lipshaw reported having no relevant financial disclosures.
Key clinical point: Evaluation and treatment of neonatal abstinence syndrome that focuses on feeding, quality of sleep, and ability to be consoled significantly reduces morphine use, compared with the established system.
Major finding: The novel ESC approach decreased morphine use, compared with the established FNASS approach (3% vs. 26%, P less than .01).
Data source: A retrospective examination of patient medical records.
Disclosures: The study was sponsored by Yale–New Haven Children’s Hospital and was not funded. Dr. Lipshaw reported having no relevant financial disclosures.
Three developmental screens differ in outcomes in comparative study
SAN FRANCISCO – The use of three different screening instruments to gauge behavioral development in children up to 5 years of age has yielded results that vary within a single practice and between different practices. This heterogeneity complicates the accurate and early identification of developmental disorders children in the primary care setting.
“The burden of diagnostic services that go along with developmental screening depends on the number of positive screens and the referral completion rate. These rates may vary markedly across practices that from the outside seem relatively homogeneous. This differential burden may help explain the variation between practices that has been observed,” said Radley Sheldrick, PhD, of Boston University School of Public Health.
The American Academy of Pediatrics has recommended the use of developmental screening instruments that have a track record in prior studies of a sensitivity and specificity of at least 70% each. Children who score positive can receive further services. The aim is laudable, Dr. Sheldrick said, but little is known of how different screens compare to one another in the results obtained, and the consistency of their performance in different practice settings.
A few years ago, Dr. Sheldrick and his colleagues at Tufts Medical Center, Boston, initiated the Screen Early, Screen Accurately for Child Well-Being (SESAW) head-to-head comparison of the effectiveness of three sets of developmental behavioral screening instruments used in the pediatric primary care setting: the Ages and Stages Questionnaire, 2nd edition (ASQ-2), Parent’s Evaluation of Developmental Status (PEDS), and the Survey of Well-Being of Young Children (SWYC).
The ASQ-2 and PEDS instruments have been in use for some time. Differences in their sensitivity and specificity of developmental concerns have been noted, although both can be used at the discretion of the physician. SWYC is a more recent instrument, which was developed at Tufts Medical Center. It was designed to be easy to read and quickly completed.
In the study, 1,000 parents of children aged 9 months to 5.5 years were enrolled at six pediatric practices in Massachusetts. About 50% of the children were boys, 10% were Hispanic, and 10% were African American. About one-quarter of the parents were receiving some form of public assistance. The parents completed the three screens. Children scoring positive on any screen were assessed further.
The researchers were especially interested in the agreement between the three screens and the variance across the six practices in the performance of the screens and the proportion of children who tested positive and actually received referral care.
Overall, about 44% of the children scored positive on at least one screen. Of these, 72% were assessed more comprehensively. A closer look at those who were assessed revealed agreement between all three screens in only 16% of the children.
The performance of the three screens was not consistent from practice to practice. Variations were evident with each screen in the different practices, and between the three screens in individual practices. The differences in the performance of the screens in the individual practices were not significantly different. However, considerable difference was noted between practices, the extreme being a 70% higher difference in one practice compared to another.
Referral completion rates also displayed variation between practices, although no significant difference was evident. Still, the extreme case was a 30% higher rate of completion of one of the practices, compared with another.
“As I’ve gotten further into this research, I’ve become struck by the number of things we don’t know about developmental screens [compared to] what we do know. Whether, for example, the sensitivity and specificity of a screen in one population carries over to other populations is an assumption we have made, but which we don’t really know,” said Dr. Sheldrick.
Another unknown is whether a developmental disorder identified by a screen at one age can be identified at a later age in someone who has not received specialized care.
Finally, the issue of false positive results is vexing. While a false positive might be suspected, not to do anything sends the wrong message.
“What to do when there is a problem between a clinical result and a screening result is one of the most important clinical questions we have right now. Clinicians have to make up their minds on this issue every day, and there is not a lot of research on it. The results need to be evaluated while recognizing that there are still some uncertainties with screening results, and recognizing other forms of information, such as parent reporting and observations of the child, that can be informative,” explained Dr. Sheldrick.
Tufts Medical Center sponsored the study, which was funded by the National Institutes of Health. Dr. Sheldrick reported having no relevant financial disclosures.
SAN FRANCISCO – The use of three different screening instruments to gauge behavioral development in children up to 5 years of age has yielded results that vary within a single practice and between different practices. This heterogeneity complicates the accurate and early identification of developmental disorders children in the primary care setting.
“The burden of diagnostic services that go along with developmental screening depends on the number of positive screens and the referral completion rate. These rates may vary markedly across practices that from the outside seem relatively homogeneous. This differential burden may help explain the variation between practices that has been observed,” said Radley Sheldrick, PhD, of Boston University School of Public Health.
The American Academy of Pediatrics has recommended the use of developmental screening instruments that have a track record in prior studies of a sensitivity and specificity of at least 70% each. Children who score positive can receive further services. The aim is laudable, Dr. Sheldrick said, but little is known of how different screens compare to one another in the results obtained, and the consistency of their performance in different practice settings.
A few years ago, Dr. Sheldrick and his colleagues at Tufts Medical Center, Boston, initiated the Screen Early, Screen Accurately for Child Well-Being (SESAW) head-to-head comparison of the effectiveness of three sets of developmental behavioral screening instruments used in the pediatric primary care setting: the Ages and Stages Questionnaire, 2nd edition (ASQ-2), Parent’s Evaluation of Developmental Status (PEDS), and the Survey of Well-Being of Young Children (SWYC).
The ASQ-2 and PEDS instruments have been in use for some time. Differences in their sensitivity and specificity of developmental concerns have been noted, although both can be used at the discretion of the physician. SWYC is a more recent instrument, which was developed at Tufts Medical Center. It was designed to be easy to read and quickly completed.
In the study, 1,000 parents of children aged 9 months to 5.5 years were enrolled at six pediatric practices in Massachusetts. About 50% of the children were boys, 10% were Hispanic, and 10% were African American. About one-quarter of the parents were receiving some form of public assistance. The parents completed the three screens. Children scoring positive on any screen were assessed further.
The researchers were especially interested in the agreement between the three screens and the variance across the six practices in the performance of the screens and the proportion of children who tested positive and actually received referral care.
Overall, about 44% of the children scored positive on at least one screen. Of these, 72% were assessed more comprehensively. A closer look at those who were assessed revealed agreement between all three screens in only 16% of the children.
The performance of the three screens was not consistent from practice to practice. Variations were evident with each screen in the different practices, and between the three screens in individual practices. The differences in the performance of the screens in the individual practices were not significantly different. However, considerable difference was noted between practices, the extreme being a 70% higher difference in one practice compared to another.
Referral completion rates also displayed variation between practices, although no significant difference was evident. Still, the extreme case was a 30% higher rate of completion of one of the practices, compared with another.
“As I’ve gotten further into this research, I’ve become struck by the number of things we don’t know about developmental screens [compared to] what we do know. Whether, for example, the sensitivity and specificity of a screen in one population carries over to other populations is an assumption we have made, but which we don’t really know,” said Dr. Sheldrick.
Another unknown is whether a developmental disorder identified by a screen at one age can be identified at a later age in someone who has not received specialized care.
Finally, the issue of false positive results is vexing. While a false positive might be suspected, not to do anything sends the wrong message.
“What to do when there is a problem between a clinical result and a screening result is one of the most important clinical questions we have right now. Clinicians have to make up their minds on this issue every day, and there is not a lot of research on it. The results need to be evaluated while recognizing that there are still some uncertainties with screening results, and recognizing other forms of information, such as parent reporting and observations of the child, that can be informative,” explained Dr. Sheldrick.
Tufts Medical Center sponsored the study, which was funded by the National Institutes of Health. Dr. Sheldrick reported having no relevant financial disclosures.
SAN FRANCISCO – The use of three different screening instruments to gauge behavioral development in children up to 5 years of age has yielded results that vary within a single practice and between different practices. This heterogeneity complicates the accurate and early identification of developmental disorders children in the primary care setting.
“The burden of diagnostic services that go along with developmental screening depends on the number of positive screens and the referral completion rate. These rates may vary markedly across practices that from the outside seem relatively homogeneous. This differential burden may help explain the variation between practices that has been observed,” said Radley Sheldrick, PhD, of Boston University School of Public Health.
The American Academy of Pediatrics has recommended the use of developmental screening instruments that have a track record in prior studies of a sensitivity and specificity of at least 70% each. Children who score positive can receive further services. The aim is laudable, Dr. Sheldrick said, but little is known of how different screens compare to one another in the results obtained, and the consistency of their performance in different practice settings.
A few years ago, Dr. Sheldrick and his colleagues at Tufts Medical Center, Boston, initiated the Screen Early, Screen Accurately for Child Well-Being (SESAW) head-to-head comparison of the effectiveness of three sets of developmental behavioral screening instruments used in the pediatric primary care setting: the Ages and Stages Questionnaire, 2nd edition (ASQ-2), Parent’s Evaluation of Developmental Status (PEDS), and the Survey of Well-Being of Young Children (SWYC).
The ASQ-2 and PEDS instruments have been in use for some time. Differences in their sensitivity and specificity of developmental concerns have been noted, although both can be used at the discretion of the physician. SWYC is a more recent instrument, which was developed at Tufts Medical Center. It was designed to be easy to read and quickly completed.
In the study, 1,000 parents of children aged 9 months to 5.5 years were enrolled at six pediatric practices in Massachusetts. About 50% of the children were boys, 10% were Hispanic, and 10% were African American. About one-quarter of the parents were receiving some form of public assistance. The parents completed the three screens. Children scoring positive on any screen were assessed further.
The researchers were especially interested in the agreement between the three screens and the variance across the six practices in the performance of the screens and the proportion of children who tested positive and actually received referral care.
Overall, about 44% of the children scored positive on at least one screen. Of these, 72% were assessed more comprehensively. A closer look at those who were assessed revealed agreement between all three screens in only 16% of the children.
The performance of the three screens was not consistent from practice to practice. Variations were evident with each screen in the different practices, and between the three screens in individual practices. The differences in the performance of the screens in the individual practices were not significantly different. However, considerable difference was noted between practices, the extreme being a 70% higher difference in one practice compared to another.
Referral completion rates also displayed variation between practices, although no significant difference was evident. Still, the extreme case was a 30% higher rate of completion of one of the practices, compared with another.
“As I’ve gotten further into this research, I’ve become struck by the number of things we don’t know about developmental screens [compared to] what we do know. Whether, for example, the sensitivity and specificity of a screen in one population carries over to other populations is an assumption we have made, but which we don’t really know,” said Dr. Sheldrick.
Another unknown is whether a developmental disorder identified by a screen at one age can be identified at a later age in someone who has not received specialized care.
Finally, the issue of false positive results is vexing. While a false positive might be suspected, not to do anything sends the wrong message.
“What to do when there is a problem between a clinical result and a screening result is one of the most important clinical questions we have right now. Clinicians have to make up their minds on this issue every day, and there is not a lot of research on it. The results need to be evaluated while recognizing that there are still some uncertainties with screening results, and recognizing other forms of information, such as parent reporting and observations of the child, that can be informative,” explained Dr. Sheldrick.
Tufts Medical Center sponsored the study, which was funded by the National Institutes of Health. Dr. Sheldrick reported having no relevant financial disclosures.
AT PAS 17
Key clinical point: There were significant differences in the results of different developmental screening instruments within and between practices in a comparative study.
Major finding: The PEDS, ASQ-2, and SWYC developmental screens coidentified only 16% of 317 children aged 9 months to 5.5 years, with significant differences in the results of each developmental screen between practices.
Data source: The Screen Early, Screen Accurately for Child Well-Being (SESAW) head-to-head comparative effectiveness trial of three sets of developmental behavioral screening instruments used in pediatric primary care.
Disclosures: Tufts Medical Center sponsored the study, which was funded by the National Institutes of Health. Dr. Sheldrick reported having no relevant financial disclosures.
UTI predictors identified in infants under 3 months of age
SAN FRANCISCO – Serum leukocytosis, pyuria, and urine leukocyte esterase have been identified as predictors of urinary tract infection (UTI) in infants younger than 90 days of age, with males being more likely to develop UTI than females.
The chance of the infection declined in older infants.
“Really young infants have a less well developed immune system, which may increase their susceptibility to UTIs,” said Sarah Berman, DO, a pediatric resident at Winthrop-University Hospital, Mineola, N.Y.
In 2011, the American Academy of Pediatrics issued “Urinary Tract Infection: Clinical Practice Guidelines for the Diagnosis and Management of the Initial UTI in Febrile Infants and Children 2 to 24 Months” (Pediatrics. 2011. doi: 10.1542/peds.2011-1330) concerning the diagnosis and management of the presence of bacteria in urine – a possible warning sign of UTI, but the AAP guidelines did not consider infants in the first 2 months of life.
To address this gap, the Winthrop-University Hospital researchers reviewed the medical records for all infants younger than 90 days of age diagnosed with UTI, fever, or viral illness from the beginning of 2009 to September 2015. Residence in neonatal intensive care, known congenital abnormalities, and prior antibiotic use were grounds for exclusion. Standard growth-based definitions of UTI and bacteriuria were used.
Of the 315 mainly white or Hispanic patients, 73 had a diagnosis of UTI and 261 did not. Both groups had the same mean age of 45 days. Fever within 24 hours of admission was more prevalent in those without UTI than those with (57% vs. 41%; P = .035). Those with UTI were significantly more likely (all P lesser than .001) to display serum leukocytosis (35% vs. 12%), pyuria (71% vs. 12%), and urine detection of leukocyte esterase (87% vs. 14%) and nitrite (19% vs. 0%).
In a univariate analysis, factors that were associated with UTI included serum leukocytosis, white blood cells in the urine, and urine leukocyte esterase, with fever within 24 hours of admission associated with reduced chance of UTI. A multivariate analysis that accounted for age, gender, and gestational age identified serum leukocytosis, pyruria, urine leukocyte esterase, and male sex as predictors of UTI, with increased odds ratio of 6.25, 3.19, 28, and 3.88, respectively.
The reduced likelihood of UTI in those who developed a fever within 24 hours of admission held up in the multivariate analysis (odds ratio 0.34).
Validation of the findings will require a prospective study, which is in the planning stage. If the findings bear out, the result could be improved diagnosis of UTI from birth onward, according to Dr. Berman.
Dr. Berman reported having no relevant financial disclosures.
SAN FRANCISCO – Serum leukocytosis, pyuria, and urine leukocyte esterase have been identified as predictors of urinary tract infection (UTI) in infants younger than 90 days of age, with males being more likely to develop UTI than females.
The chance of the infection declined in older infants.
“Really young infants have a less well developed immune system, which may increase their susceptibility to UTIs,” said Sarah Berman, DO, a pediatric resident at Winthrop-University Hospital, Mineola, N.Y.
In 2011, the American Academy of Pediatrics issued “Urinary Tract Infection: Clinical Practice Guidelines for the Diagnosis and Management of the Initial UTI in Febrile Infants and Children 2 to 24 Months” (Pediatrics. 2011. doi: 10.1542/peds.2011-1330) concerning the diagnosis and management of the presence of bacteria in urine – a possible warning sign of UTI, but the AAP guidelines did not consider infants in the first 2 months of life.
To address this gap, the Winthrop-University Hospital researchers reviewed the medical records for all infants younger than 90 days of age diagnosed with UTI, fever, or viral illness from the beginning of 2009 to September 2015. Residence in neonatal intensive care, known congenital abnormalities, and prior antibiotic use were grounds for exclusion. Standard growth-based definitions of UTI and bacteriuria were used.
Of the 315 mainly white or Hispanic patients, 73 had a diagnosis of UTI and 261 did not. Both groups had the same mean age of 45 days. Fever within 24 hours of admission was more prevalent in those without UTI than those with (57% vs. 41%; P = .035). Those with UTI were significantly more likely (all P lesser than .001) to display serum leukocytosis (35% vs. 12%), pyuria (71% vs. 12%), and urine detection of leukocyte esterase (87% vs. 14%) and nitrite (19% vs. 0%).
In a univariate analysis, factors that were associated with UTI included serum leukocytosis, white blood cells in the urine, and urine leukocyte esterase, with fever within 24 hours of admission associated with reduced chance of UTI. A multivariate analysis that accounted for age, gender, and gestational age identified serum leukocytosis, pyruria, urine leukocyte esterase, and male sex as predictors of UTI, with increased odds ratio of 6.25, 3.19, 28, and 3.88, respectively.
The reduced likelihood of UTI in those who developed a fever within 24 hours of admission held up in the multivariate analysis (odds ratio 0.34).
Validation of the findings will require a prospective study, which is in the planning stage. If the findings bear out, the result could be improved diagnosis of UTI from birth onward, according to Dr. Berman.
Dr. Berman reported having no relevant financial disclosures.
SAN FRANCISCO – Serum leukocytosis, pyuria, and urine leukocyte esterase have been identified as predictors of urinary tract infection (UTI) in infants younger than 90 days of age, with males being more likely to develop UTI than females.
The chance of the infection declined in older infants.
“Really young infants have a less well developed immune system, which may increase their susceptibility to UTIs,” said Sarah Berman, DO, a pediatric resident at Winthrop-University Hospital, Mineola, N.Y.
In 2011, the American Academy of Pediatrics issued “Urinary Tract Infection: Clinical Practice Guidelines for the Diagnosis and Management of the Initial UTI in Febrile Infants and Children 2 to 24 Months” (Pediatrics. 2011. doi: 10.1542/peds.2011-1330) concerning the diagnosis and management of the presence of bacteria in urine – a possible warning sign of UTI, but the AAP guidelines did not consider infants in the first 2 months of life.
To address this gap, the Winthrop-University Hospital researchers reviewed the medical records for all infants younger than 90 days of age diagnosed with UTI, fever, or viral illness from the beginning of 2009 to September 2015. Residence in neonatal intensive care, known congenital abnormalities, and prior antibiotic use were grounds for exclusion. Standard growth-based definitions of UTI and bacteriuria were used.
Of the 315 mainly white or Hispanic patients, 73 had a diagnosis of UTI and 261 did not. Both groups had the same mean age of 45 days. Fever within 24 hours of admission was more prevalent in those without UTI than those with (57% vs. 41%; P = .035). Those with UTI were significantly more likely (all P lesser than .001) to display serum leukocytosis (35% vs. 12%), pyuria (71% vs. 12%), and urine detection of leukocyte esterase (87% vs. 14%) and nitrite (19% vs. 0%).
In a univariate analysis, factors that were associated with UTI included serum leukocytosis, white blood cells in the urine, and urine leukocyte esterase, with fever within 24 hours of admission associated with reduced chance of UTI. A multivariate analysis that accounted for age, gender, and gestational age identified serum leukocytosis, pyruria, urine leukocyte esterase, and male sex as predictors of UTI, with increased odds ratio of 6.25, 3.19, 28, and 3.88, respectively.
The reduced likelihood of UTI in those who developed a fever within 24 hours of admission held up in the multivariate analysis (odds ratio 0.34).
Validation of the findings will require a prospective study, which is in the planning stage. If the findings bear out, the result could be improved diagnosis of UTI from birth onward, according to Dr. Berman.
Dr. Berman reported having no relevant financial disclosures.
AT PAS 17
Key clinical point: Pyuria, urine leukocyte esterase, and serum leukocytosis appear to be predictors of urinary tract infection in infants younger than 90 days of age.
Major finding: A multivariate analysis identified serum leukocytosis, pyruria, and urine leukocyte esterase as predictors of UTI, with increased odds ratio of 6.25, 3.19, and 28, respectively.
Data source: Retrospective analysis of medical records from one hospital.
Disclosures: Dr. Berman reported having no relevant financial disclosures.
Breastfeeding among factors that modify neonatal abstinence syndrome
SAN FRANCISCO – The good news of a prospective, multicenter study presented at the Pediatric Academic Societies meeting was that neonates who were breastfed were less likely to require neonatal abstinence syndrome (NAS) treatment and displayed milder symptoms.
The study also identified other risk factors associated with the need for NAS treatment and the severity of NAS.
“These findings are important because many of these risk factors are modifiable. Prenatal care providers strive to provide the best treatments for both the mother and the fetus. Our findings regarding the association of NAS with some maternal drug exposures can be shared with opiate-dependent mothers during general counseling about tobacco and illicit use in pregnancy and in counseling about NAS,” explained Megan Stover, MD, a fellow in maternal-fetal medicine and genetics at Tufts Medical Center in Boston.
The current standard of care for opioid-dependent pregnant women is medication-assisted treatment with either methadone or buprenorphine. The intervention can be effective in curbing continued opioid abuse and preventing relapse. However, for many of their unborn children, the damage has already been done.
The scope of the problem in the United States is staggering. Between 2004 and 2013, there was a fourfold to fivefold increase in the rate of admissions to neonatal intensive care units (NICUs) for NAS. “It has been estimated that, every minute in the United States, one neonate will require treatment for NAS,” said Dr. Stover. The glum reality for the Tufts researchers is that 50%-80% of opiate-exposed infants will require treatment for NAS. The aim is to reduce this rate.
Dr. Stover was part of a study conducted at hospitals on the U.S. East Coast that aimed to clarify factors before and after birth that were associated with NAS. The enrolled mothers had been treated during their third trimester or following admission for birth for opioid dependence or had received an opioid for relief of chronic pain. They had given birth to their child at term.
Neonates who were born prematurely or who had comorbidities judged to be significant were not part of the analyses. Of the 306 neonates included, 52% required treatment for NAS and 48% did not. The two groups were similar in age of the mother and for neonatal characteristics of gestational age, sex, ethnicity, and body measurements at birth. The severity of NAS was gauged in two ways. One was the number of days of treatment required to free the neonates from the opioid-induced symptoms, with less than 10 days indicating mild NAS, greater than 30 days indicating severe NAS, and the intervening days indicating moderate NAS. Severe NAS also was indicated by the use of two or more medications.
There was good news. Neonates were significantly less likely to require NAS treatment if they were breastfed exclusively, compared with formula fed babies (15% vs 67%; P less than .0001). NAS was usually mild in breastfed babies and often severe in formula-fed babies (P less than .002).
“Our findings regarding the favorable outcomes seen with breastfeeding support recent research regarding the influence of nonpharmacologic approaches to the prevention and management of NAS, namely that more soothing environments, like those outside the NICU, may be more optimal settings for infants undergoing surveillance for NAS,” said Dr. Stover.
Neonatal treatment was more prevalent for women whose opioid substitution therapy involved methadone (54% vs 28% of untreated neonates; P less than .0001). When therapy used buprenorphine, 62% of the neonates did not display NAS. The drug used for substitution therapy had no effect on the length of treatment of the neonates.
“Our data regarding methadone exposure [versus buprenorphine] adds to a growing literature surrounding more favorable neonatal effects seen with this opiate maintenance agent over methadone,” commented Dr. Stover.
NAS treatment was more prevalent for mothers who smoked during pregnancy, compared with those who did not (76% vs 42%; P equal to .02), and for maternal use of illicit drugs (50% vs 34%; P equal to .002), with no effect on length of neonatal treatment.
Maternal psychiatric diagnosis was associated with neonatal NAS (P equal to .03), as was prescription benzodiazepine use in the third trimester of pregnancy (P equal to .02). Benzodiazepine use did not influence the length of treatment. However, maternal alprazolam use did, as it was associated with more severe NAS (P less than .001). Use of selective serotonin reuptake inhibitor during pregnancy was also associated with more severe NAS (P equal to 0.01).
The researchers are currently sifting through the genetic data gathered in the study. The goal is to combine the clinical and genetic data to create a risk score that will be used to tailor care before birth and in the early weeks following birth.
The study was sponsored by Tufts Medical Center and was funded by National Institute on Drug Abuse. Dr. Stover reported having no relevant financial disclosures.
SAN FRANCISCO – The good news of a prospective, multicenter study presented at the Pediatric Academic Societies meeting was that neonates who were breastfed were less likely to require neonatal abstinence syndrome (NAS) treatment and displayed milder symptoms.
The study also identified other risk factors associated with the need for NAS treatment and the severity of NAS.
“These findings are important because many of these risk factors are modifiable. Prenatal care providers strive to provide the best treatments for both the mother and the fetus. Our findings regarding the association of NAS with some maternal drug exposures can be shared with opiate-dependent mothers during general counseling about tobacco and illicit use in pregnancy and in counseling about NAS,” explained Megan Stover, MD, a fellow in maternal-fetal medicine and genetics at Tufts Medical Center in Boston.
The current standard of care for opioid-dependent pregnant women is medication-assisted treatment with either methadone or buprenorphine. The intervention can be effective in curbing continued opioid abuse and preventing relapse. However, for many of their unborn children, the damage has already been done.
The scope of the problem in the United States is staggering. Between 2004 and 2013, there was a fourfold to fivefold increase in the rate of admissions to neonatal intensive care units (NICUs) for NAS. “It has been estimated that, every minute in the United States, one neonate will require treatment for NAS,” said Dr. Stover. The glum reality for the Tufts researchers is that 50%-80% of opiate-exposed infants will require treatment for NAS. The aim is to reduce this rate.
Dr. Stover was part of a study conducted at hospitals on the U.S. East Coast that aimed to clarify factors before and after birth that were associated with NAS. The enrolled mothers had been treated during their third trimester or following admission for birth for opioid dependence or had received an opioid for relief of chronic pain. They had given birth to their child at term.
Neonates who were born prematurely or who had comorbidities judged to be significant were not part of the analyses. Of the 306 neonates included, 52% required treatment for NAS and 48% did not. The two groups were similar in age of the mother and for neonatal characteristics of gestational age, sex, ethnicity, and body measurements at birth. The severity of NAS was gauged in two ways. One was the number of days of treatment required to free the neonates from the opioid-induced symptoms, with less than 10 days indicating mild NAS, greater than 30 days indicating severe NAS, and the intervening days indicating moderate NAS. Severe NAS also was indicated by the use of two or more medications.
There was good news. Neonates were significantly less likely to require NAS treatment if they were breastfed exclusively, compared with formula fed babies (15% vs 67%; P less than .0001). NAS was usually mild in breastfed babies and often severe in formula-fed babies (P less than .002).
“Our findings regarding the favorable outcomes seen with breastfeeding support recent research regarding the influence of nonpharmacologic approaches to the prevention and management of NAS, namely that more soothing environments, like those outside the NICU, may be more optimal settings for infants undergoing surveillance for NAS,” said Dr. Stover.
Neonatal treatment was more prevalent for women whose opioid substitution therapy involved methadone (54% vs 28% of untreated neonates; P less than .0001). When therapy used buprenorphine, 62% of the neonates did not display NAS. The drug used for substitution therapy had no effect on the length of treatment of the neonates.
“Our data regarding methadone exposure [versus buprenorphine] adds to a growing literature surrounding more favorable neonatal effects seen with this opiate maintenance agent over methadone,” commented Dr. Stover.
NAS treatment was more prevalent for mothers who smoked during pregnancy, compared with those who did not (76% vs 42%; P equal to .02), and for maternal use of illicit drugs (50% vs 34%; P equal to .002), with no effect on length of neonatal treatment.
Maternal psychiatric diagnosis was associated with neonatal NAS (P equal to .03), as was prescription benzodiazepine use in the third trimester of pregnancy (P equal to .02). Benzodiazepine use did not influence the length of treatment. However, maternal alprazolam use did, as it was associated with more severe NAS (P less than .001). Use of selective serotonin reuptake inhibitor during pregnancy was also associated with more severe NAS (P equal to 0.01).
The researchers are currently sifting through the genetic data gathered in the study. The goal is to combine the clinical and genetic data to create a risk score that will be used to tailor care before birth and in the early weeks following birth.
The study was sponsored by Tufts Medical Center and was funded by National Institute on Drug Abuse. Dr. Stover reported having no relevant financial disclosures.
SAN FRANCISCO – The good news of a prospective, multicenter study presented at the Pediatric Academic Societies meeting was that neonates who were breastfed were less likely to require neonatal abstinence syndrome (NAS) treatment and displayed milder symptoms.
The study also identified other risk factors associated with the need for NAS treatment and the severity of NAS.
“These findings are important because many of these risk factors are modifiable. Prenatal care providers strive to provide the best treatments for both the mother and the fetus. Our findings regarding the association of NAS with some maternal drug exposures can be shared with opiate-dependent mothers during general counseling about tobacco and illicit use in pregnancy and in counseling about NAS,” explained Megan Stover, MD, a fellow in maternal-fetal medicine and genetics at Tufts Medical Center in Boston.
The current standard of care for opioid-dependent pregnant women is medication-assisted treatment with either methadone or buprenorphine. The intervention can be effective in curbing continued opioid abuse and preventing relapse. However, for many of their unborn children, the damage has already been done.
The scope of the problem in the United States is staggering. Between 2004 and 2013, there was a fourfold to fivefold increase in the rate of admissions to neonatal intensive care units (NICUs) for NAS. “It has been estimated that, every minute in the United States, one neonate will require treatment for NAS,” said Dr. Stover. The glum reality for the Tufts researchers is that 50%-80% of opiate-exposed infants will require treatment for NAS. The aim is to reduce this rate.
Dr. Stover was part of a study conducted at hospitals on the U.S. East Coast that aimed to clarify factors before and after birth that were associated with NAS. The enrolled mothers had been treated during their third trimester or following admission for birth for opioid dependence or had received an opioid for relief of chronic pain. They had given birth to their child at term.
Neonates who were born prematurely or who had comorbidities judged to be significant were not part of the analyses. Of the 306 neonates included, 52% required treatment for NAS and 48% did not. The two groups were similar in age of the mother and for neonatal characteristics of gestational age, sex, ethnicity, and body measurements at birth. The severity of NAS was gauged in two ways. One was the number of days of treatment required to free the neonates from the opioid-induced symptoms, with less than 10 days indicating mild NAS, greater than 30 days indicating severe NAS, and the intervening days indicating moderate NAS. Severe NAS also was indicated by the use of two or more medications.
There was good news. Neonates were significantly less likely to require NAS treatment if they were breastfed exclusively, compared with formula fed babies (15% vs 67%; P less than .0001). NAS was usually mild in breastfed babies and often severe in formula-fed babies (P less than .002).
“Our findings regarding the favorable outcomes seen with breastfeeding support recent research regarding the influence of nonpharmacologic approaches to the prevention and management of NAS, namely that more soothing environments, like those outside the NICU, may be more optimal settings for infants undergoing surveillance for NAS,” said Dr. Stover.
Neonatal treatment was more prevalent for women whose opioid substitution therapy involved methadone (54% vs 28% of untreated neonates; P less than .0001). When therapy used buprenorphine, 62% of the neonates did not display NAS. The drug used for substitution therapy had no effect on the length of treatment of the neonates.
“Our data regarding methadone exposure [versus buprenorphine] adds to a growing literature surrounding more favorable neonatal effects seen with this opiate maintenance agent over methadone,” commented Dr. Stover.
NAS treatment was more prevalent for mothers who smoked during pregnancy, compared with those who did not (76% vs 42%; P equal to .02), and for maternal use of illicit drugs (50% vs 34%; P equal to .002), with no effect on length of neonatal treatment.
Maternal psychiatric diagnosis was associated with neonatal NAS (P equal to .03), as was prescription benzodiazepine use in the third trimester of pregnancy (P equal to .02). Benzodiazepine use did not influence the length of treatment. However, maternal alprazolam use did, as it was associated with more severe NAS (P less than .001). Use of selective serotonin reuptake inhibitor during pregnancy was also associated with more severe NAS (P equal to 0.01).
The researchers are currently sifting through the genetic data gathered in the study. The goal is to combine the clinical and genetic data to create a risk score that will be used to tailor care before birth and in the early weeks following birth.
The study was sponsored by Tufts Medical Center and was funded by National Institute on Drug Abuse. Dr. Stover reported having no relevant financial disclosures.
AT PAS 2017
Key clinical point: Clinical factors associated with the need for treatment of neonatal abstinence syndrome and for its severity were identified.
Major finding: Breastfeeding was also associated with less severe NAS (P equal to .0003).
Data source: Prospective cohort analysis as part of a multisite trial.
Disclosures: The study was sponsored by Tufts Medical Center and was funded by the National Institute on Drug Abuse. Dr. Stover reported having no relevant financial disclosures.
Buprenorphine is an alternative to morphine in treating NAS
SAN FRANCISCO – The phase III, single-center Blinded Buprenorphine or Neonatal Morphine Solution (BBORN) clinical trial has established the efficacy of buprenorphine as an alternative to morphine for treatment of newborns with neonatal abstinence syndrome (NAS).
The strategy cuts the treatment time needed to relieve the withdrawal symptoms of the infants by nearly half, the researchers reported. The study results, presented at the Pediatric Academic Societies meeting, were simultaneously published in the New England Journal of Medicine (2017. doi: 10.1056/NEJMoa1614835).
“For those infants who ultimately require pharmacologic treatment, the BBORN trial demonstrated that buprenorphine has similar safety and improved efficacy in length of treatment and length of stay compared to morphine, which is used in 80% of neonatal intensive care units,” said Walter K. Kraft, MD, of Thomas Jefferson University, Philadelphia,.
In the trial, 63 term infants (greater than and equal to 37 weeks of gestation) exposed to opioids prior to birth and who displayed signs of NAS were randomized to receive sublingual buprenorphine or oral morphine. Prior exposure to benzodiazepine in the 30 days before birth, medical or neurologic illness, and elevated bilirubin were grounds for exclusion.
The primary endpoint was the length of treatment needed to deal with the withdrawal symptoms. Secondary endpoints included length of hospitalization, need for supplementary treatment with phenobarbital, and safety.
The groups were comparable at baseline, with the exception of median gestational age in the buprenorphine group (38.5 vs. 39.0 weeks, P = .03). Most of the infants were white. Almost all mothers were on maintenance methadone therapy and almost all were current smokers. Thirty-three infants were randomized to receive buprenorphine. Three withdrew and were treated with open-label morphine. Thirty infants received morphine, with two withdrawing to the open-label treatment.
Those receiving buprenorphine displayed significantly shorter median duration of treatment (15 vs. 28 days) and median length of hospital stay (21 vs. 33 days) (both P less than .001). The use of supplemental phenobarbital was similar in both groups.
Occurrence of adverse events was similar, with 13 events in 7 infants in the buprenorphine group and 10 events in 8 infants in the morphine group. One serious event occurred in each group; neither was treatment related.
“The trial only proves that buprenorphine works but does not answer how. We suspect a long half-life is a part of the answer, though methadone also has a long half-life. We have not compared buprenorphine to methadone for treatment of infants with neonatal abstinence syndrome. We conjecture that as a partial agonist, weaning may be smoother. In our trial, it was a shorter wean time, rather than quicker control of symptoms, in which buprenorphine was more effective than morphine. Buprenorphine has effects on other receptors, but it is very unclear if this added to efficacy relative to morphine,” explained Dr. Kraft.
“Regarding mechanism, it is believed that the somatic (as opposed to the drug craving) symptoms of opiate withdrawal in the adult arise from areas of the brainstem called the locus coeruleus and periaqueductal gray, which express opiate receptors. These areas are undergoing major developmental changes in utero and at the time of birth. Therefore, although we hypothesize that the withdrawal symptoms in the infants are likely arising from the same regions, it has not been proven, and is actually something we are investigating in rodent models,” explained the study’s main author, Michelle Ehrlich, MD, of Icahn School of Medicine at Mount Sinai, New York.
While the trial’s findings presented at PAS 17 are an advance in the armamentarium of care for NAS, the researchers are adamant that the approach should not be seen as a stand-alone treatment.
“I would stress than an approach to treatment of neonatal abstinence syndrome most importantly be multidisciplinary and use a uniform institutional protocol. For example, there should be standardization of Finnegan scoring with continuous quality improvement. All babies should have nonpharmacologic treatment of breastfeeding, rooming in, and minimization of excessive stimuli,” explained Dr. Kraft.
Next steps include clarifying the pharmacokinetics to optimize the dose, and to assess the influence of buprenorphine on neurobehavior. “We suspect the mechanism of action to be similar to that of adults. However, how the biology of neonatal abstinence syndrome differs from opioid withdrawal of adults is not known and [is] an area in need of more investigation. We did collect pharmacokinetic samples, and these data are currently being analyzed,” said Dr. Kraft.
Thomas Jefferson University sponsored the study, which was funded by the National Institute on Drug Abuse. Dr. Kraft reported serving as an unpaid consultant to Chiesi Farmaceutici S.p.A. Dr. Ehrlich disclosed receipt of buprenorphine from Indivior for the study and grants from NIDA.
SAN FRANCISCO – The phase III, single-center Blinded Buprenorphine or Neonatal Morphine Solution (BBORN) clinical trial has established the efficacy of buprenorphine as an alternative to morphine for treatment of newborns with neonatal abstinence syndrome (NAS).
The strategy cuts the treatment time needed to relieve the withdrawal symptoms of the infants by nearly half, the researchers reported. The study results, presented at the Pediatric Academic Societies meeting, were simultaneously published in the New England Journal of Medicine (2017. doi: 10.1056/NEJMoa1614835).
“For those infants who ultimately require pharmacologic treatment, the BBORN trial demonstrated that buprenorphine has similar safety and improved efficacy in length of treatment and length of stay compared to morphine, which is used in 80% of neonatal intensive care units,” said Walter K. Kraft, MD, of Thomas Jefferson University, Philadelphia,.
In the trial, 63 term infants (greater than and equal to 37 weeks of gestation) exposed to opioids prior to birth and who displayed signs of NAS were randomized to receive sublingual buprenorphine or oral morphine. Prior exposure to benzodiazepine in the 30 days before birth, medical or neurologic illness, and elevated bilirubin were grounds for exclusion.
The primary endpoint was the length of treatment needed to deal with the withdrawal symptoms. Secondary endpoints included length of hospitalization, need for supplementary treatment with phenobarbital, and safety.
The groups were comparable at baseline, with the exception of median gestational age in the buprenorphine group (38.5 vs. 39.0 weeks, P = .03). Most of the infants were white. Almost all mothers were on maintenance methadone therapy and almost all were current smokers. Thirty-three infants were randomized to receive buprenorphine. Three withdrew and were treated with open-label morphine. Thirty infants received morphine, with two withdrawing to the open-label treatment.
Those receiving buprenorphine displayed significantly shorter median duration of treatment (15 vs. 28 days) and median length of hospital stay (21 vs. 33 days) (both P less than .001). The use of supplemental phenobarbital was similar in both groups.
Occurrence of adverse events was similar, with 13 events in 7 infants in the buprenorphine group and 10 events in 8 infants in the morphine group. One serious event occurred in each group; neither was treatment related.
“The trial only proves that buprenorphine works but does not answer how. We suspect a long half-life is a part of the answer, though methadone also has a long half-life. We have not compared buprenorphine to methadone for treatment of infants with neonatal abstinence syndrome. We conjecture that as a partial agonist, weaning may be smoother. In our trial, it was a shorter wean time, rather than quicker control of symptoms, in which buprenorphine was more effective than morphine. Buprenorphine has effects on other receptors, but it is very unclear if this added to efficacy relative to morphine,” explained Dr. Kraft.
“Regarding mechanism, it is believed that the somatic (as opposed to the drug craving) symptoms of opiate withdrawal in the adult arise from areas of the brainstem called the locus coeruleus and periaqueductal gray, which express opiate receptors. These areas are undergoing major developmental changes in utero and at the time of birth. Therefore, although we hypothesize that the withdrawal symptoms in the infants are likely arising from the same regions, it has not been proven, and is actually something we are investigating in rodent models,” explained the study’s main author, Michelle Ehrlich, MD, of Icahn School of Medicine at Mount Sinai, New York.
While the trial’s findings presented at PAS 17 are an advance in the armamentarium of care for NAS, the researchers are adamant that the approach should not be seen as a stand-alone treatment.
“I would stress than an approach to treatment of neonatal abstinence syndrome most importantly be multidisciplinary and use a uniform institutional protocol. For example, there should be standardization of Finnegan scoring with continuous quality improvement. All babies should have nonpharmacologic treatment of breastfeeding, rooming in, and minimization of excessive stimuli,” explained Dr. Kraft.
Next steps include clarifying the pharmacokinetics to optimize the dose, and to assess the influence of buprenorphine on neurobehavior. “We suspect the mechanism of action to be similar to that of adults. However, how the biology of neonatal abstinence syndrome differs from opioid withdrawal of adults is not known and [is] an area in need of more investigation. We did collect pharmacokinetic samples, and these data are currently being analyzed,” said Dr. Kraft.
Thomas Jefferson University sponsored the study, which was funded by the National Institute on Drug Abuse. Dr. Kraft reported serving as an unpaid consultant to Chiesi Farmaceutici S.p.A. Dr. Ehrlich disclosed receipt of buprenorphine from Indivior for the study and grants from NIDA.
SAN FRANCISCO – The phase III, single-center Blinded Buprenorphine or Neonatal Morphine Solution (BBORN) clinical trial has established the efficacy of buprenorphine as an alternative to morphine for treatment of newborns with neonatal abstinence syndrome (NAS).
The strategy cuts the treatment time needed to relieve the withdrawal symptoms of the infants by nearly half, the researchers reported. The study results, presented at the Pediatric Academic Societies meeting, were simultaneously published in the New England Journal of Medicine (2017. doi: 10.1056/NEJMoa1614835).
“For those infants who ultimately require pharmacologic treatment, the BBORN trial demonstrated that buprenorphine has similar safety and improved efficacy in length of treatment and length of stay compared to morphine, which is used in 80% of neonatal intensive care units,” said Walter K. Kraft, MD, of Thomas Jefferson University, Philadelphia,.
In the trial, 63 term infants (greater than and equal to 37 weeks of gestation) exposed to opioids prior to birth and who displayed signs of NAS were randomized to receive sublingual buprenorphine or oral morphine. Prior exposure to benzodiazepine in the 30 days before birth, medical or neurologic illness, and elevated bilirubin were grounds for exclusion.
The primary endpoint was the length of treatment needed to deal with the withdrawal symptoms. Secondary endpoints included length of hospitalization, need for supplementary treatment with phenobarbital, and safety.
The groups were comparable at baseline, with the exception of median gestational age in the buprenorphine group (38.5 vs. 39.0 weeks, P = .03). Most of the infants were white. Almost all mothers were on maintenance methadone therapy and almost all were current smokers. Thirty-three infants were randomized to receive buprenorphine. Three withdrew and were treated with open-label morphine. Thirty infants received morphine, with two withdrawing to the open-label treatment.
Those receiving buprenorphine displayed significantly shorter median duration of treatment (15 vs. 28 days) and median length of hospital stay (21 vs. 33 days) (both P less than .001). The use of supplemental phenobarbital was similar in both groups.
Occurrence of adverse events was similar, with 13 events in 7 infants in the buprenorphine group and 10 events in 8 infants in the morphine group. One serious event occurred in each group; neither was treatment related.
“The trial only proves that buprenorphine works but does not answer how. We suspect a long half-life is a part of the answer, though methadone also has a long half-life. We have not compared buprenorphine to methadone for treatment of infants with neonatal abstinence syndrome. We conjecture that as a partial agonist, weaning may be smoother. In our trial, it was a shorter wean time, rather than quicker control of symptoms, in which buprenorphine was more effective than morphine. Buprenorphine has effects on other receptors, but it is very unclear if this added to efficacy relative to morphine,” explained Dr. Kraft.
“Regarding mechanism, it is believed that the somatic (as opposed to the drug craving) symptoms of opiate withdrawal in the adult arise from areas of the brainstem called the locus coeruleus and periaqueductal gray, which express opiate receptors. These areas are undergoing major developmental changes in utero and at the time of birth. Therefore, although we hypothesize that the withdrawal symptoms in the infants are likely arising from the same regions, it has not been proven, and is actually something we are investigating in rodent models,” explained the study’s main author, Michelle Ehrlich, MD, of Icahn School of Medicine at Mount Sinai, New York.
While the trial’s findings presented at PAS 17 are an advance in the armamentarium of care for NAS, the researchers are adamant that the approach should not be seen as a stand-alone treatment.
“I would stress than an approach to treatment of neonatal abstinence syndrome most importantly be multidisciplinary and use a uniform institutional protocol. For example, there should be standardization of Finnegan scoring with continuous quality improvement. All babies should have nonpharmacologic treatment of breastfeeding, rooming in, and minimization of excessive stimuli,” explained Dr. Kraft.
Next steps include clarifying the pharmacokinetics to optimize the dose, and to assess the influence of buprenorphine on neurobehavior. “We suspect the mechanism of action to be similar to that of adults. However, how the biology of neonatal abstinence syndrome differs from opioid withdrawal of adults is not known and [is] an area in need of more investigation. We did collect pharmacokinetic samples, and these data are currently being analyzed,” said Dr. Kraft.
Thomas Jefferson University sponsored the study, which was funded by the National Institute on Drug Abuse. Dr. Kraft reported serving as an unpaid consultant to Chiesi Farmaceutici S.p.A. Dr. Ehrlich disclosed receipt of buprenorphine from Indivior for the study and grants from NIDA.
AT PAS 17
Key clinical point:
Major finding: Buprenorphine reduced median length of treatment (15 vs. 28 days, P less than .001) and median length of stay (21 vs. 34.5 days, P less than .001), compared with morphine.
Data source: Double-blind, double-dummy, single-site, randomized clinical trial (NCT01452789).
Disclosures: Thomas Jefferson University sponsored the study, which was funded by the National Institute on Drug Abuse. Dr. Kraft reported serving as an unpaid consultant to Chiesi Farmaceutici S.p.A. Dr. Ehrlich disclosed receipt of buprenorphine from Indivior for the study and grants from NIDA.
Constipation implicated as an indicator of Helicobacter pylori infection
SAN FRANCISCO – Infants refractory constipation and chronic abdominal pain should be tested for the presence of Helicobacter pylori infection. Just relying on the detection of antigen to H. pylori in stool may not be a definitive indicator of the bacterial infection; endoscopic biopsy is a more specific test, according to study findings presented at the Pediatric Academic Societies meeting.
“Our study highlights that constipation seems to be prevalent among children who test positive for H. pylori in stool. No other predominant symptom was found to be related to H. pylori infection,” said Ayesha Baig, MD, a third-year resident at Brookdale University Hospital and Medical Center in Brooklyn, N.Y.
Gastritis that results from H. pylori infection in the mucous membrane lining the stomach is extremely common in children and adolescents. Yet, diagnosis remains challenging, with disagreement about the hallmark symptoms to look for in making the diagnosis.
The researchers retrospectively examined the medical records of patients aged 2-18 years who had been treated for chronic abdominal pain at the hospital’s gastrointestinal clinic between late 2013 and mid-2016. One aim was to see if there was a predominant symptom in patients in whom H. pylori infection had been proven by the detection of antibody to the bacteria in stool and/or in an endoscopic biopsy. Other aims were to identify a relationship between symptoms and the two methods of detecting H. pylori, and to see if symptoms varied with age. Other gastrointestinal disorders were not considered.
The majority (60%) of the 91 patients were male. Most were African American. Their mean age was 10-12 years.
The presence of nausea, vomiting, diarrhea, constipation, blood in stool, and prior history of use of proton pump inhibitors were compared in those testing positive and negative for H. pylori.
Of the patients who were constipated, 72% tested positive for H. pylori in stool and 28% of tested positive for H. pylori in endoscopic biopsy. In patients testing positive for H. pylori based on the presence of antigen in the stool, about 40% tested negative using endoscopic biopsy.
Age was irrelevant concerning biopsy results and symptoms.
“A proportion of patients who tested positive for H. pylori stool antigen tested negative for H. pylori using endoscopic biopsy, which is a higher-specificity method. Our study indicated that stool antigen alone is not a definitive indicator for treating H. pylori,” said Dr. Baig.
The influence of empiric treatment is still an open question that needs examination.
Dr. Baig reported having no relevant financial disclosures.
*This article was updated on 5/24/2017.
SAN FRANCISCO – Infants refractory constipation and chronic abdominal pain should be tested for the presence of Helicobacter pylori infection. Just relying on the detection of antigen to H. pylori in stool may not be a definitive indicator of the bacterial infection; endoscopic biopsy is a more specific test, according to study findings presented at the Pediatric Academic Societies meeting.
“Our study highlights that constipation seems to be prevalent among children who test positive for H. pylori in stool. No other predominant symptom was found to be related to H. pylori infection,” said Ayesha Baig, MD, a third-year resident at Brookdale University Hospital and Medical Center in Brooklyn, N.Y.
Gastritis that results from H. pylori infection in the mucous membrane lining the stomach is extremely common in children and adolescents. Yet, diagnosis remains challenging, with disagreement about the hallmark symptoms to look for in making the diagnosis.
The researchers retrospectively examined the medical records of patients aged 2-18 years who had been treated for chronic abdominal pain at the hospital’s gastrointestinal clinic between late 2013 and mid-2016. One aim was to see if there was a predominant symptom in patients in whom H. pylori infection had been proven by the detection of antibody to the bacteria in stool and/or in an endoscopic biopsy. Other aims were to identify a relationship between symptoms and the two methods of detecting H. pylori, and to see if symptoms varied with age. Other gastrointestinal disorders were not considered.
The majority (60%) of the 91 patients were male. Most were African American. Their mean age was 10-12 years.
The presence of nausea, vomiting, diarrhea, constipation, blood in stool, and prior history of use of proton pump inhibitors were compared in those testing positive and negative for H. pylori.
Of the patients who were constipated, 72% tested positive for H. pylori in stool and 28% of tested positive for H. pylori in endoscopic biopsy. In patients testing positive for H. pylori based on the presence of antigen in the stool, about 40% tested negative using endoscopic biopsy.
Age was irrelevant concerning biopsy results and symptoms.
“A proportion of patients who tested positive for H. pylori stool antigen tested negative for H. pylori using endoscopic biopsy, which is a higher-specificity method. Our study indicated that stool antigen alone is not a definitive indicator for treating H. pylori,” said Dr. Baig.
The influence of empiric treatment is still an open question that needs examination.
Dr. Baig reported having no relevant financial disclosures.
*This article was updated on 5/24/2017.
SAN FRANCISCO – Infants refractory constipation and chronic abdominal pain should be tested for the presence of Helicobacter pylori infection. Just relying on the detection of antigen to H. pylori in stool may not be a definitive indicator of the bacterial infection; endoscopic biopsy is a more specific test, according to study findings presented at the Pediatric Academic Societies meeting.
“Our study highlights that constipation seems to be prevalent among children who test positive for H. pylori in stool. No other predominant symptom was found to be related to H. pylori infection,” said Ayesha Baig, MD, a third-year resident at Brookdale University Hospital and Medical Center in Brooklyn, N.Y.
Gastritis that results from H. pylori infection in the mucous membrane lining the stomach is extremely common in children and adolescents. Yet, diagnosis remains challenging, with disagreement about the hallmark symptoms to look for in making the diagnosis.
The researchers retrospectively examined the medical records of patients aged 2-18 years who had been treated for chronic abdominal pain at the hospital’s gastrointestinal clinic between late 2013 and mid-2016. One aim was to see if there was a predominant symptom in patients in whom H. pylori infection had been proven by the detection of antibody to the bacteria in stool and/or in an endoscopic biopsy. Other aims were to identify a relationship between symptoms and the two methods of detecting H. pylori, and to see if symptoms varied with age. Other gastrointestinal disorders were not considered.
The majority (60%) of the 91 patients were male. Most were African American. Their mean age was 10-12 years.
The presence of nausea, vomiting, diarrhea, constipation, blood in stool, and prior history of use of proton pump inhibitors were compared in those testing positive and negative for H. pylori.
Of the patients who were constipated, 72% tested positive for H. pylori in stool and 28% of tested positive for H. pylori in endoscopic biopsy. In patients testing positive for H. pylori based on the presence of antigen in the stool, about 40% tested negative using endoscopic biopsy.
Age was irrelevant concerning biopsy results and symptoms.
“A proportion of patients who tested positive for H. pylori stool antigen tested negative for H. pylori using endoscopic biopsy, which is a higher-specificity method. Our study indicated that stool antigen alone is not a definitive indicator for treating H. pylori,” said Dr. Baig.
The influence of empiric treatment is still an open question that needs examination.
Dr. Baig reported having no relevant financial disclosures.
*This article was updated on 5/24/2017.
AT PAS 17
Key clinical point:
Major finding: Seventy-two percent and 28% of patients who were constipated tested positive for H. pylori in stool and in endoscopic biopsy, respectively.
Data source: Retrospective case-control study from a single medical center.
Disclosures: Dr. Baig reported having no relevant financial disclosures.
Serum magnesium level reflects risk of death, irrespective of CKD
CHICAGO – Low levels of serum magnesium were associated with increased all-cause mortality, whether or not patients had chronic kidney disease, in a single center, retrospective study of 3,551 people.
The association was independent of sociodemographic factors, comorbidities, and use of diuretics.
If causality is shown, “magnesium supplementation could be a simple therapy to lessen the chance of death in CKD patients,” study investigator Silvia Ferrè, PhD, University of Texas Southwestern, Dallas, said in an interview regarding the results of the Dallas Heart Study, which was presented at the annual meeting of the American Society of Nephrology.
In both groups, the subjects with low serum magnesium were younger, more likely to be female, had a higher body mass index, and were more burdened by comorbidities including type 2 diabetes mellitus and hypertension. Subjects without CKD and low serum magnesium were significantly more likely to use diuretics. Diuretic use was comparable in subjects with CKD regardless of serum magnesium level.
Irrespective of CKD status, survival was significantly lower in subjects with low serum magnesium in the median 12.3-year follow-up compared to the other two serum magnesium tertiles (P less than 0.001 and P equal to 0.03, respectively). Following adjustment for age, gender, race/ethnicity, body mass index, phosphorus, calcium, bicarbonate, albumin, intact parathyroid hormone, total cholesterol, high-density lipoprotein, and use of diuretics and supplements, low serum magnesium was independently associated with all-cause death in subjects with CKD (Hazard Ratio, 1.92; 9%% Confidence Interval, 1.03 to 3.59; P equal to 0.04) and those without CKD (HR, 1.43; 1.43; 95% CI, 0.95 to 2.15; P equal to 0.09), when compared to high serum magnesium as the referent.
Dr. Ferrè said that screening for serum magnesium and supplementation with magnesium as part of routine blood testing might improve survival. Low magnesium level alsonhas been linked with osteoporosis, diabetes, and cardiovascular disease.
The Dallas Heart Study was a multiethnic, population-based study involving 6,101 adults residing in Dallas County. The study, which ran from 2000 to the end of 2011, was designed to explore the early detection of cardiovascular disease and the social, behavioral, and environmental factors associated with risk, with the goal of interventions that can be provided at the community level.
The study sponsor was University of Texas Southwestern Medical Center. The study was funded by the National Institutes of Health and the Donald W. Reynolds Foundation. Dr. Ferrè reported having no financial disclosures.
CHICAGO – Low levels of serum magnesium were associated with increased all-cause mortality, whether or not patients had chronic kidney disease, in a single center, retrospective study of 3,551 people.
The association was independent of sociodemographic factors, comorbidities, and use of diuretics.
If causality is shown, “magnesium supplementation could be a simple therapy to lessen the chance of death in CKD patients,” study investigator Silvia Ferrè, PhD, University of Texas Southwestern, Dallas, said in an interview regarding the results of the Dallas Heart Study, which was presented at the annual meeting of the American Society of Nephrology.
In both groups, the subjects with low serum magnesium were younger, more likely to be female, had a higher body mass index, and were more burdened by comorbidities including type 2 diabetes mellitus and hypertension. Subjects without CKD and low serum magnesium were significantly more likely to use diuretics. Diuretic use was comparable in subjects with CKD regardless of serum magnesium level.
Irrespective of CKD status, survival was significantly lower in subjects with low serum magnesium in the median 12.3-year follow-up compared to the other two serum magnesium tertiles (P less than 0.001 and P equal to 0.03, respectively). Following adjustment for age, gender, race/ethnicity, body mass index, phosphorus, calcium, bicarbonate, albumin, intact parathyroid hormone, total cholesterol, high-density lipoprotein, and use of diuretics and supplements, low serum magnesium was independently associated with all-cause death in subjects with CKD (Hazard Ratio, 1.92; 9%% Confidence Interval, 1.03 to 3.59; P equal to 0.04) and those without CKD (HR, 1.43; 1.43; 95% CI, 0.95 to 2.15; P equal to 0.09), when compared to high serum magnesium as the referent.
Dr. Ferrè said that screening for serum magnesium and supplementation with magnesium as part of routine blood testing might improve survival. Low magnesium level alsonhas been linked with osteoporosis, diabetes, and cardiovascular disease.
The Dallas Heart Study was a multiethnic, population-based study involving 6,101 adults residing in Dallas County. The study, which ran from 2000 to the end of 2011, was designed to explore the early detection of cardiovascular disease and the social, behavioral, and environmental factors associated with risk, with the goal of interventions that can be provided at the community level.
The study sponsor was University of Texas Southwestern Medical Center. The study was funded by the National Institutes of Health and the Donald W. Reynolds Foundation. Dr. Ferrè reported having no financial disclosures.
CHICAGO – Low levels of serum magnesium were associated with increased all-cause mortality, whether or not patients had chronic kidney disease, in a single center, retrospective study of 3,551 people.
The association was independent of sociodemographic factors, comorbidities, and use of diuretics.
If causality is shown, “magnesium supplementation could be a simple therapy to lessen the chance of death in CKD patients,” study investigator Silvia Ferrè, PhD, University of Texas Southwestern, Dallas, said in an interview regarding the results of the Dallas Heart Study, which was presented at the annual meeting of the American Society of Nephrology.
In both groups, the subjects with low serum magnesium were younger, more likely to be female, had a higher body mass index, and were more burdened by comorbidities including type 2 diabetes mellitus and hypertension. Subjects without CKD and low serum magnesium were significantly more likely to use diuretics. Diuretic use was comparable in subjects with CKD regardless of serum magnesium level.
Irrespective of CKD status, survival was significantly lower in subjects with low serum magnesium in the median 12.3-year follow-up compared to the other two serum magnesium tertiles (P less than 0.001 and P equal to 0.03, respectively). Following adjustment for age, gender, race/ethnicity, body mass index, phosphorus, calcium, bicarbonate, albumin, intact parathyroid hormone, total cholesterol, high-density lipoprotein, and use of diuretics and supplements, low serum magnesium was independently associated with all-cause death in subjects with CKD (Hazard Ratio, 1.92; 9%% Confidence Interval, 1.03 to 3.59; P equal to 0.04) and those without CKD (HR, 1.43; 1.43; 95% CI, 0.95 to 2.15; P equal to 0.09), when compared to high serum magnesium as the referent.
Dr. Ferrè said that screening for serum magnesium and supplementation with magnesium as part of routine blood testing might improve survival. Low magnesium level alsonhas been linked with osteoporosis, diabetes, and cardiovascular disease.
The Dallas Heart Study was a multiethnic, population-based study involving 6,101 adults residing in Dallas County. The study, which ran from 2000 to the end of 2011, was designed to explore the early detection of cardiovascular disease and the social, behavioral, and environmental factors associated with risk, with the goal of interventions that can be provided at the community level.
The study sponsor was University of Texas Southwestern Medical Center. The study was funded by the National Institutes of Health and the Donald W. Reynolds Foundation. Dr. Ferrè reported having no financial disclosures.
AT THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR NEPHROLOGY
Key clinical point: If causality is shown, magnesium supplementation could be a simple therapy to reduce mortality in patients with chronic kidney disease.
Major finding: Low serum magnesium was significantly associated with risk of death in patients without CKD (P less than 0.01) and patients with CKD (P equal to 0.03).
Data source: A single-center, retrospective cohort of 3,551 patients in the Dallas Heart Study.
Disclosures: The study sponsor was University of Texas Southwestern Medical Center. The study was funded by the National Institutes of Health and the Donald W. Reynolds Foundation. Dr. Ferrè reported having no financial disclosures.
Constipation severity linked with chronic kidney disease and decline in kidney function
CHICAGO – Constipation was associated with poor kidney health in a large nationwide cohort of 3.5 million United States veterans, and researchers are considering whether effectively treating constipation could help prevent or treat kidney disease.
“In this large nationwide cohort ... patients with constipation had higher risks of developing chronic kidney disease and end-stage renal disease, and were more likely to experience rapid decline in kidney function, even after adjusting for various known risk factors. We also found that more severe constipation was associated with an incrementally higher risk for both incident CKD (chronic kidney disease) and ESRD (end-stage renal disease),” said Keiichi Sumida, MD, a visiting scholar at the University of Tennessee Health Science Center in Memphis.
In a multivariable analysis, those with constipation had a 13% higher likelihood of developing CKD (Hazard Ratio, 1.13; 95% Confidence Interval, 1.11 to 1.14) and a 9% higher likelihood of developing ESRD (HR, 1.09; 95% CI, 1.01 to 1.18) compared to those without constipation. As well, those with constipation experienced a faster decline in estimated glomerular filtration ratio (eGFR).
Scrutiny of US Veterans Administration databases identified nearly 4.5 million patients with serum creatinine measurements obtained between October 2004 and September 2006. Of these, 3,504,732 patients had an eGFR greater than or equal to 60 ml/min/1.73 m2 but no other symptoms of CKD. All were followed through 2013.
Constipation was defined as at least two ICD-9-CM diagnoses for constipation made at least 60 days apart or two or more prescriptions for laxatives separated by 60 days for up to a year. The severity of constipation was based on the number of different type of laxatives prescribed, with no laxative use being considered as absence of constipation, one laxative type being indicative of mild constipation, and two or more types of laxatives being indicative of severe constipation.
Co-primary outcomes were incident CKD, incident ESRD, and change in eGFR from baseline. As expected in the propensity-matched cohort, baseline demographic and clinical characteristics were comparable for the 3,251,291 individuals who experienced constipation and the 253,441 individuals who did not.
“Our findings highlight the plausible link between the gut and the kidneys, and provide additional insights into the pathogenesis of kidney disease progression. Our results suggest the need for careful observation of kidney function in patients with constipation, particularly among those with more severe constipation,” Dr. Sumida concluded.
Dr. Sumida hypothesized that altered gut microflora in constipation may result in inflammation, changes in metabolites, or accumulation of toxins. Alternative explanations increased serotonin related to laxative use, nephrotoxicity, dehydration, or electrolyte imbalance.
These possibilities need to be examined, as does the idea that relieving constipation could prevent renal decline. “Given the high prevalence of constipation in the general population and the simplicity of its assessment in primary care settings, the management of constipation through lifestyle modifications and/or use of probiotics rather than laxatives could become a useful tool in preventing the development of CKD, or in retarding the progression of existing CKD,” Dr. Sumida said.
CHICAGO – Constipation was associated with poor kidney health in a large nationwide cohort of 3.5 million United States veterans, and researchers are considering whether effectively treating constipation could help prevent or treat kidney disease.
“In this large nationwide cohort ... patients with constipation had higher risks of developing chronic kidney disease and end-stage renal disease, and were more likely to experience rapid decline in kidney function, even after adjusting for various known risk factors. We also found that more severe constipation was associated with an incrementally higher risk for both incident CKD (chronic kidney disease) and ESRD (end-stage renal disease),” said Keiichi Sumida, MD, a visiting scholar at the University of Tennessee Health Science Center in Memphis.
In a multivariable analysis, those with constipation had a 13% higher likelihood of developing CKD (Hazard Ratio, 1.13; 95% Confidence Interval, 1.11 to 1.14) and a 9% higher likelihood of developing ESRD (HR, 1.09; 95% CI, 1.01 to 1.18) compared to those without constipation. As well, those with constipation experienced a faster decline in estimated glomerular filtration ratio (eGFR).
Scrutiny of US Veterans Administration databases identified nearly 4.5 million patients with serum creatinine measurements obtained between October 2004 and September 2006. Of these, 3,504,732 patients had an eGFR greater than or equal to 60 ml/min/1.73 m2 but no other symptoms of CKD. All were followed through 2013.
Constipation was defined as at least two ICD-9-CM diagnoses for constipation made at least 60 days apart or two or more prescriptions for laxatives separated by 60 days for up to a year. The severity of constipation was based on the number of different type of laxatives prescribed, with no laxative use being considered as absence of constipation, one laxative type being indicative of mild constipation, and two or more types of laxatives being indicative of severe constipation.
Co-primary outcomes were incident CKD, incident ESRD, and change in eGFR from baseline. As expected in the propensity-matched cohort, baseline demographic and clinical characteristics were comparable for the 3,251,291 individuals who experienced constipation and the 253,441 individuals who did not.
“Our findings highlight the plausible link between the gut and the kidneys, and provide additional insights into the pathogenesis of kidney disease progression. Our results suggest the need for careful observation of kidney function in patients with constipation, particularly among those with more severe constipation,” Dr. Sumida concluded.
Dr. Sumida hypothesized that altered gut microflora in constipation may result in inflammation, changes in metabolites, or accumulation of toxins. Alternative explanations increased serotonin related to laxative use, nephrotoxicity, dehydration, or electrolyte imbalance.
These possibilities need to be examined, as does the idea that relieving constipation could prevent renal decline. “Given the high prevalence of constipation in the general population and the simplicity of its assessment in primary care settings, the management of constipation through lifestyle modifications and/or use of probiotics rather than laxatives could become a useful tool in preventing the development of CKD, or in retarding the progression of existing CKD,” Dr. Sumida said.
CHICAGO – Constipation was associated with poor kidney health in a large nationwide cohort of 3.5 million United States veterans, and researchers are considering whether effectively treating constipation could help prevent or treat kidney disease.
“In this large nationwide cohort ... patients with constipation had higher risks of developing chronic kidney disease and end-stage renal disease, and were more likely to experience rapid decline in kidney function, even after adjusting for various known risk factors. We also found that more severe constipation was associated with an incrementally higher risk for both incident CKD (chronic kidney disease) and ESRD (end-stage renal disease),” said Keiichi Sumida, MD, a visiting scholar at the University of Tennessee Health Science Center in Memphis.
In a multivariable analysis, those with constipation had a 13% higher likelihood of developing CKD (Hazard Ratio, 1.13; 95% Confidence Interval, 1.11 to 1.14) and a 9% higher likelihood of developing ESRD (HR, 1.09; 95% CI, 1.01 to 1.18) compared to those without constipation. As well, those with constipation experienced a faster decline in estimated glomerular filtration ratio (eGFR).
Scrutiny of US Veterans Administration databases identified nearly 4.5 million patients with serum creatinine measurements obtained between October 2004 and September 2006. Of these, 3,504,732 patients had an eGFR greater than or equal to 60 ml/min/1.73 m2 but no other symptoms of CKD. All were followed through 2013.
Constipation was defined as at least two ICD-9-CM diagnoses for constipation made at least 60 days apart or two or more prescriptions for laxatives separated by 60 days for up to a year. The severity of constipation was based on the number of different type of laxatives prescribed, with no laxative use being considered as absence of constipation, one laxative type being indicative of mild constipation, and two or more types of laxatives being indicative of severe constipation.
Co-primary outcomes were incident CKD, incident ESRD, and change in eGFR from baseline. As expected in the propensity-matched cohort, baseline demographic and clinical characteristics were comparable for the 3,251,291 individuals who experienced constipation and the 253,441 individuals who did not.
“Our findings highlight the plausible link between the gut and the kidneys, and provide additional insights into the pathogenesis of kidney disease progression. Our results suggest the need for careful observation of kidney function in patients with constipation, particularly among those with more severe constipation,” Dr. Sumida concluded.
Dr. Sumida hypothesized that altered gut microflora in constipation may result in inflammation, changes in metabolites, or accumulation of toxins. Alternative explanations increased serotonin related to laxative use, nephrotoxicity, dehydration, or electrolyte imbalance.
These possibilities need to be examined, as does the idea that relieving constipation could prevent renal decline. “Given the high prevalence of constipation in the general population and the simplicity of its assessment in primary care settings, the management of constipation through lifestyle modifications and/or use of probiotics rather than laxatives could become a useful tool in preventing the development of CKD, or in retarding the progression of existing CKD,” Dr. Sumida said.
AT THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR NEPHROLOGY
Key clinical point: Presence and severity of constipation increases the risks of developing chronic kidney disease and end stage renal disease, and accelerates the decline in kidney function.
Major finding: Individuals with constipation were 13% more likely to develop chronic kidney disease and 9% more likely to develop end stage renal disease compared to those without constipation.
Data source: Retrospective analysis of Veteran’s Administration databases. The study included 3,504,732 subjects.
Disclosures: The study sponsor was the University of Tennessee Health Science Center. Funding was provided by the United States Department of Veterans Affairs. Dr. Sumida reported having no financial disclosures.
Cell ratios predict short-term possibility of death in patients beginning hemodialysis
CHICAGO – Two simple-to-calculate ratios – neutrophil lymphocyte ratio and platelet lymphocyte ratio – may be able to predict impending death in patients who have recently begun hemodialysis, based on data from 108,548 incident hemodialysis patients in the database of DaVita HealthCare Partners from 2007 to 2011.
“Neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR), and inflammatory and nutritional indices, which are calculated from complete blood count, were identified as strong predictors of impending death ... and thus are inexpensive and immediately available markers for predicting short-term mortality,” said Yoshitsugu Obi, MD, PhD, a visiting scholar at the Harold Simmons Center for Kidney Disease Research & Epidemiology, University of California Irvine School of Medicine, Irvine, California.
The data were obtained from the database of a large dialysis organization; 108,548 patients who began hemodialysis from 2007 to 2011 were included. The range of NLR values were divided into 12 categories with ratios of less than 1.5 and greater than or equal to 6.5 as the bracketing ratios. The 10 other intervening ratios differed incrementally by 0.5. Eight SLR categories were created with the bracketing ratios being less than 5 and greater than or equal to 35. The intervening six ratios differed incrementally by 5.
The mean age of the cohort was 63 ± 15 years. Males predominated (56%), 59% of the subjects were diabetic, and 31% were African American. At baseline the median NLR and PLR were 3.64 and 13.12, respectively.
In an unadjusted regression analysis, the categories of NLR and PLR had a strong and linear relationship with all-cause mortality. In an analysis that adjusted for covariates, including demographics and comorbidities, as well as markers of malnutrition and inflammation, the association of the two ratios with all-cause mortality persisted.
Unlike previous small and inconclusive studies, the size of the present study makes robust the connection between these cell ratios and death in dialysis patients, he said. The plan now is to compare the mortality predictability of NLR and PLR with other established risk factors including albumin, phosphorus, and alkaline phosphatase.
CHICAGO – Two simple-to-calculate ratios – neutrophil lymphocyte ratio and platelet lymphocyte ratio – may be able to predict impending death in patients who have recently begun hemodialysis, based on data from 108,548 incident hemodialysis patients in the database of DaVita HealthCare Partners from 2007 to 2011.
“Neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR), and inflammatory and nutritional indices, which are calculated from complete blood count, were identified as strong predictors of impending death ... and thus are inexpensive and immediately available markers for predicting short-term mortality,” said Yoshitsugu Obi, MD, PhD, a visiting scholar at the Harold Simmons Center for Kidney Disease Research & Epidemiology, University of California Irvine School of Medicine, Irvine, California.
The data were obtained from the database of a large dialysis organization; 108,548 patients who began hemodialysis from 2007 to 2011 were included. The range of NLR values were divided into 12 categories with ratios of less than 1.5 and greater than or equal to 6.5 as the bracketing ratios. The 10 other intervening ratios differed incrementally by 0.5. Eight SLR categories were created with the bracketing ratios being less than 5 and greater than or equal to 35. The intervening six ratios differed incrementally by 5.
The mean age of the cohort was 63 ± 15 years. Males predominated (56%), 59% of the subjects were diabetic, and 31% were African American. At baseline the median NLR and PLR were 3.64 and 13.12, respectively.
In an unadjusted regression analysis, the categories of NLR and PLR had a strong and linear relationship with all-cause mortality. In an analysis that adjusted for covariates, including demographics and comorbidities, as well as markers of malnutrition and inflammation, the association of the two ratios with all-cause mortality persisted.
Unlike previous small and inconclusive studies, the size of the present study makes robust the connection between these cell ratios and death in dialysis patients, he said. The plan now is to compare the mortality predictability of NLR and PLR with other established risk factors including albumin, phosphorus, and alkaline phosphatase.
CHICAGO – Two simple-to-calculate ratios – neutrophil lymphocyte ratio and platelet lymphocyte ratio – may be able to predict impending death in patients who have recently begun hemodialysis, based on data from 108,548 incident hemodialysis patients in the database of DaVita HealthCare Partners from 2007 to 2011.
“Neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR), and inflammatory and nutritional indices, which are calculated from complete blood count, were identified as strong predictors of impending death ... and thus are inexpensive and immediately available markers for predicting short-term mortality,” said Yoshitsugu Obi, MD, PhD, a visiting scholar at the Harold Simmons Center for Kidney Disease Research & Epidemiology, University of California Irvine School of Medicine, Irvine, California.
The data were obtained from the database of a large dialysis organization; 108,548 patients who began hemodialysis from 2007 to 2011 were included. The range of NLR values were divided into 12 categories with ratios of less than 1.5 and greater than or equal to 6.5 as the bracketing ratios. The 10 other intervening ratios differed incrementally by 0.5. Eight SLR categories were created with the bracketing ratios being less than 5 and greater than or equal to 35. The intervening six ratios differed incrementally by 5.
The mean age of the cohort was 63 ± 15 years. Males predominated (56%), 59% of the subjects were diabetic, and 31% were African American. At baseline the median NLR and PLR were 3.64 and 13.12, respectively.
In an unadjusted regression analysis, the categories of NLR and PLR had a strong and linear relationship with all-cause mortality. In an analysis that adjusted for covariates, including demographics and comorbidities, as well as markers of malnutrition and inflammation, the association of the two ratios with all-cause mortality persisted.
Unlike previous small and inconclusive studies, the size of the present study makes robust the connection between these cell ratios and death in dialysis patients, he said. The plan now is to compare the mortality predictability of NLR and PLR with other established risk factors including albumin, phosphorus, and alkaline phosphatase.
AT THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR NEPHROLOGY
Key clinical point: The neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR) are strongly associated with imminent death in patients who have recently started hemodialysis.
Major finding: Increasing NLR and PLR were linearly associated with death in 108,548 hemodialysis patients.
Data source: Database of DaVita HealthCare Partners from 2007 to 2011.
Disclosures: The study was sponsored by University of Irvine School of Medicine. The study was funded by the National Institutes of Health. Dr. Obi had no disclosures.