NIH-funded findings highlight need for clinical trials to determine best treatment options
Medical care for newborn infants who were exposed to opioids in the womb varied widely across 30 hospitals nationwide, according to a study funded by the National Institutes of Health. The study authors say that the findings underscore the need for clinical trials to determine the most effective treatments.
The study was conducted by Leslie Young, M.D., of the University of Vermont and colleagues in the Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW) Program, part of NIH’s Helping to End Addiction Long-term Initiative. It appears in the journal Pediatrics.
Opioid use disorder during pregnancy increased from 1.5 to 6.5 for every 1,000 hospital deliveries from 1999 to 2014, according to the U.S. Centers for Disease Control and Prevention. Opioid use during pregnancy increases the risk for maternal death, miscarriage, poor fetal growth and preterm birth. Newborns who are exposed to opioids in the womb may also have withdrawal symptoms that require medication treatment.
ACT NOW study sites varied widely in the proportion of pregnant women who received medication-assisted treatment (from roughly 6% to 100%) and prenatal counseling (roughly 2% to about 75%). Sites also varied greatly in the proportion of newborns receiving therapy with a replacement opioid (about 7% to 100%) and therapy with a secondary medication to further ease the infants’ withdrawal symptoms (roughly 1% to roughly 70%).
The study authors concluded that understanding the wide variation in treatment offered to opioid-addicted mothers and their infants is an important first step for planning future studies and treatment programs.
Funding for the study was provided by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Environmental influences on Child Health Outcomes (ECHO) Program in NIH’s Office of the Director.
Andrew Bremer, M.D., Acting Chief of the NICHD Pregnancy and Perinatology Branch, and Alan Simon, M.D., Medical Officer in the ECHO IDeA States Pediatric Clinical Trials Network, are available for comment.
Young, LW, et al. Site level variation in the characteristics and care of infants with neonatal opioid withdrawal. Pediatrics. 2020.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. For more information, visit https://www.nichd.nih.gov.
About the Environmental influences on Child Health Outcomes (ECHO) Program: ECHO aims to enhance the health of children for generations to come. Research conducted through ECHO focuses on five key pediatric outcomes: pre-, peri- and postnatal outcomes; upper and lower airway health; obesity; neurodevelopment; and positive health. For more information, visit: https://echochildren.org .
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov.