Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
HELP for NOWS Consortium
Summary
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.
Description
Neonatal Opioid Withdrawal Syndrome (NOWS) occurs in infants who were exposed to opioids during pregnancy and may lead to symptoms such as irritability, feeding difficulties, and trouble sleeping. Many hospitals treat these symptoms with either morphine or buprenorphine, but it is not yet known whether one medication helps infants recover more quickly. This study aims to answer that question by reviewing information already documented in medical records from hospitals that routinely use one of these treatments. The study will include approximately 796 infants, all born at 36 weeks' of gestati…
Eligibility
- Age range
- 0+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Infant is ≥ 36 weeks' gestational age 2. Infant had antenatal opioid exposure identified by at least one of the following: 1. 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; 2. Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or 3. Positive infant toxicology screen for opioids during the initial hospital stay. 3. The infant is being assessed and managed for NOWS at an eligible study site. 4. The infant is at risk for p…
Locations (22)
- University of Alabama at BirminghamBirmingham, Alabama
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- ChristianaCareWilmington, Delaware
- University of South Florida HealthTampa, Florida
- Riley Hospital for Children at IU HealthIndianapolis, Indiana
- Sidney & Lois Eskenazi HospitalIndianapolis, Indiana