Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

Part of paid clinical trials in Birmingham, Alabama.

Sponsor: HELP for NOWS Consortium
Study ID: NCT07278375
Status: Recruiting

Conditions

Neonatal Opioid Withdrawal Syndrome

Eligibility Criteria

Sex: ALL
Age: 0 Minutes - N/A
Healthy Volunteers: Not accepted

Study Details

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 Dates

Start date: Dec 9, 2025
Status verified: Feb 2026
Primary completion: Jun 19, 2026
Completion: Aug 30, 2026

Study Design

Enrollment: 796 participants (estimated)

Arms

Arm: Infants treated with buprenorphine
Infants treated with buprenorphine as the primary opioid for NOWS
Arm: Infants treated with morphine
Infants treated with morphine as the primary opioid for NOWS

Primary Outcome Measure

Time from birth until infant meets criteria for medically ready for discharge (count) [ Time Frame: From date of birth until date of infant meeting criteria for medically ready for discharge (estimated to be < 90 days). ]

Central Contacts

Walter K Kraft, MD
215-955-9077
[email protected]

Locations (22)

Facility	City	State	ZIP	Site coordinators
University of Alabama at Birmingham	Birmingham	Alabama	35294	Namasivayam Ambalavanan, MD Namasivayam Ambalavanan, MD (PRINCIPAL_INVESTIGATOR)
University of Arkansas for Medical Sciences	Little Rock	Arkansas	72205-7199	Richard W Hall, MD [email protected] 501-686-8000 Richard W Hall, MD (PRINCIPAL_INVESTIGATOR)
ChristianaCare	Wilmington	Delaware	19801	Kelley Kovatis, MD [email protected] 215-427-5000 Kelley Z Kovatis, MD (PRINCIPAL_INVESTIGATOR)
University of South Florida Health	Tampa	Florida	33606	Tanner Wright, MD, FAAP [email protected] 321-217-2235 Tanner Wright, MD, FAAP (PRINCIPAL_INVESTIGATOR)
Riley Hospital for Children at IU Health	Indianapolis	Indiana	46202-5119	Gregory Sokol, MD [email protected] 317-274-8021 Gregory Sokol, MD (PRINCIPAL_INVESTIGATOR)
Sidney & Lois Eskenazi Hospital	Indianapolis	Indiana	46202	Gregory Sokol, MD [email protected] 317-274-8021 Gregory Sokol, MD (PRINCIPAL_INVESTIGATOR)
University of Louisville Hospital	Jeffersonville	Indiana	47130	Lori Devlin, DO, MHA, MS [email protected] 502-852-8470 Lori Devlin, DO, MHA, MS (PRINCIPAL_INVESTIGATOR)
St. Elizabeth Healthcare	Edgewood	Kentucky	41017	Stephanie Merhar, MD, MS [email protected] 513-803-5180 Stephanie Merhar, MD, MS (PRINCIPAL_INVESTIGATOR)
Kentucky Children's Hospital	Lexington	Kentucky	40536	Thitinart Sithisarn, MD, PhD [email protected] 859-257-6481 Thitinart Sithisarn, MD, PhD, FAAP (PRINCIPAL_INVESTIGATOR)
Norton Children's Hospital	Louisville	Kentucky	40202	Lori Devlin, DO, MHA, MS [email protected] 502-852-8470 Lori Devlin, DO, MHA, MS (PRINCIPAL_INVESTIGATOR)
Norton Women's and Children's Hospital	Louisville	Kentucky	40207	Lori Devlin, DO, MHA, MS [email protected] 502-852-8470 Lori Devlin, DO, MHA, MS (PRINCIPAL_INVESTIGATOR)
Children's Regional Hospital, Cooper University Health Care	Camden	New Jersey	08103	Alla Kushnir, MD, FAAP [email protected] 856-342-2265 Alla Kushnir, MD, FAAP (PRINCIPAL_INVESTIGATOR)
University of New Mexico Health Sciences Center	Albuquerque	New Mexico	87131	Lawrence Leeman, MD, MPH [email protected] 505-272-2165 Lawrence M Leeman, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of Rochester Medical Center	Rochester	New York	14642	Joseph Bliss, MD, PhD [email protected] 585-275-9767 Joseph Bliss, MD, PhD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Stephanie Merhar, MD, MS [email protected] 513-803-5180 Stephanie Merhar, MD, MS (PRINCIPAL_INVESTIGATOR)
Good Samaritan Hospital	Cincinnati	Ohio	45202	Stephanie Merhar, MD, MS [email protected] 513-803-5180 Stephanie Merhar, MD, MS (PRINCIPAL_INVESTIGATOR)
Rainbow Babies and Children's Hospital	Cleveland	Ohio	44106	Moira Crowley, MD [email protected] 216-844-3759 Moira Crowley, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Scott Lorch, MD, MSCE [email protected] 215-590-1653 Scott Lorch, MD, MSCE (PRINCIPAL_INVESTIGATOR)
Pennsylvania Hospital	Philadelphia	Pennsylvania	19107	Karen Puopolo, MD, PhD [email protected] 215-829-3301 Karen Puopolo, MD, PhD (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	19107	Walter Kraft, MD [email protected] 501-686-8000 Walter K Kraft, MD (PRINCIPAL_INVESTIGATOR)
University of Utah Health	Salt Lake City	Utah	84158	Bhanu Muniyappa, MD [email protected] 801-581-2205 Bhanu Muniyappa, MD (PRINCIPAL_INVESTIGATOR)
University of Vermont Medical Center	Burlington	Vermont	05401	Adrienne Pahl, MD [email protected] 802-847-2700 Adrienne Pahl, MD (PRINCIPAL_INVESTIGATOR)

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