Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

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.

NCT Number	NCT07278375
Lead Sponsor	HELP for NOWS Consortium Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions	Neonatal Opioid Withdrawal Syndrome
Enrollment	796 participants
Start Date	2025-12-09
Primary Completion	2026-06-19 (estimated)
Study Completion	2026-08-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-25