Actively Recruiting
Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
Led by HELP for NOWS Consortium · Updated on 2026-02-25
796
Participants Needed
22
Research Sites
37 weeks
Total Duration
On this page
Sponsors
H
HELP for NOWS Consortium
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant is at least 36 weeks' gestational age
- Infant had opioid exposure before birth confirmed by maternal history or toxicology during pregnancy or infant toxicology during hospital stay
- Infant is being assessed and managed for NOWS at a study site
- Infant is at risk for pharmacologic treatment for NOWS based on scoring tools
- Infant met all inclusion criteria on or after March 25, 2024
You will not qualify if you...
- Infant has major congenital anomalies
- Infant has neonatal encephalopathy, metabolic disorder, stroke, intracranial hemorrhage, or meningitis before treatment
- Infant is receiving respiratory support at 48 hours of age
- Infant had major surgery before or at 48 hours of age
- Infant had opioid exposure after birth before starting treatment
- Infant was born outside and started treatment at a different hospital
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205-7199
Actively Recruiting
3
ChristianaCare
Wilmington, Delaware, United States, 19801
Not Yet Recruiting
4
University of South Florida Health
Tampa, Florida, United States, 33606
Actively Recruiting
5
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States, 46202-5119
Actively Recruiting
6
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
University of Louisville Hospital
Jeffersonville, Indiana, United States, 47130
Not Yet Recruiting
8
St. Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
Not Yet Recruiting
9
Kentucky Children's Hospital
Lexington, Kentucky, United States, 40536
Actively Recruiting
10
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
11
Norton Women's and Children's Hospital
Louisville, Kentucky, United States, 40207
Not Yet Recruiting
12
Children's Regional Hospital, Cooper University Health Care
Camden, New Jersey, United States, 08103
Not Yet Recruiting
13
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
14
University of Rochester Medical Center
Rochester, New York, United States, 14642
Not Yet Recruiting
15
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45202
Not Yet Recruiting
16
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
17
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
18
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
19
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
20
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
21
University of Utah Health
Salt Lake City, Utah, United States, 84158
Not Yet Recruiting
22
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Not Yet Recruiting
Research Team
W
Walter K Kraft, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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