MedTrace Logo

Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

NCT07278375 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 796

Last updated 2026-02-25

No results posted yet for this study

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.

Conditions

  • Neonatal Opioid Withdrawal Syndrome

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • HELP for NOWS Consortium

    lead NETWORK

Eligibility

Min Age
0 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-09
Primary Completion
2026-06-19
Completion
2026-08-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07278375 on ClinicalTrials.gov