The goal of this observational study is to learn how two medicines used in routine care-buprenorphine and morphine-affect recovery in newborns (≥36 weeks' gestation) with Neonatal Opioid Withdrawal Syndrome (NOWS). The main questions it aims to answer are:
1. Do infants treated with buprenorphine become medically ready for discharge sooner than those treated with morphine? 2. Does one treatment lead to better overall clinical outcomes than the other?
Researchers will compare infants who received buprenorphine with infants who received morphine to see whether one treatment helps babies recover more quickly.
Participants will not be asked to do anything. Instead, the study team will collect information already documented in the infant's and mother's medical records securely without any contact or changes to clinical care.
No new medicines, procedures, or visits are involved. This study only reviews existing clinical data to better understand which commonly used treatment may support faster recovery for newborns with NOWS.
Infant is ≥ 36 weeks' gestational age
History of maternal opioid use during the second and/or third trimester of pregnancy as noted in the mother's or infant's medical record;
Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or
Positive infant toxicology screen for opioids during the initial hospital stay.
Infant has major congenital anomalies.
Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior to the initiation of pharmacologic treatment.
Infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
Infant has undergone major surgical intervention prior to or at 48 hours of age.
HELP for NOWS Consortium
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator