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Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
Sponsor: 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.
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
Conditions
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