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RECRUITING
NCT07278375

Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

Sponsor: HELP for NOWS Consortium

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

0 Minutes - Any

Study Type

OBSERVATIONAL

Enrollment

796

Start Date

2025-12-09

Completion Date

2026-08-30

Last Updated

2026-02-25

Healthy Volunteers

No

Locations (22)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

ChristianaCare

Wilmington, Delaware, United States

University of South Florida Health

Tampa, Florida, United States

Riley Hospital for Children at IU Health

Indianapolis, Indiana, United States

Sidney & Lois Eskenazi Hospital

Indianapolis, Indiana, United States

University of Louisville Hospital

Jeffersonville, Indiana, United States

St. Elizabeth Healthcare

Edgewood, Kentucky, United States

Kentucky Children's Hospital

Lexington, Kentucky, United States

Norton Children's Hospital

Louisville, Kentucky, United States

Norton Women's and Children's Hospital

Louisville, Kentucky, United States

Children's Regional Hospital, Cooper University Health Care

Camden, New Jersey, United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

University of Rochester Medical Center

Rochester, New York, United States

Good Samaritan Hospital

Cincinnati, Ohio, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

University of Utah Health

Salt Lake City, Utah, United States

University of Vermont Medical Center

Burlington, Vermont, United States