Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

Recruiting now

Conditions studied: Neonatal Opioid Withdrawal Syndrome

In brief

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 facts

Study ID

NCT07278375

Run by

HELP for NOWS Consortium

People needed

796

Starts

2025-12-09

Expected to finish

2026-08-30

Last updated by the study team

2026-02-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infant is ≥ 36 weeks' gestational age
• Infant had antenatal opioid exposure identified by at least one of the following:
• History of maternal opioid use during the second and/or third trimester of pregnancy as noted in the mother's or infant's medical record;
• Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or
• Positive infant toxicology screen for opioids during the initial hospital stay.
• The infant is being assessed and managed for NOWS at an eligible study site.
• The infant is at risk for pharmacologic treatment for NOWS defined by either of the following:
• At least 1 score ≥ 8 if assessed and managed with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) or modification thereof
• At least 1 "yes" if assessed and managed with the Eat, Sleep, Console (ESC) care approach
• Infant met all inclusion criteria on or after March 25, 2024.

You may not qualify if…

• Infant has major congenital anomalies.
• Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior to the initiation of pharmacologic treatment.
• Infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
• Infant has undergone major surgical intervention prior to or at 48 hours of age.
• Infant has postnatal opioid exposure prior to the initiation of pharmacologic treatment for NOWS.
• Infant was outborn and pharmacologic treatment was initiated at the transferring hospital.

Where it is running

• University of South Florida Health — Tampa, Florida, United States (enrolling)
• Kentucky Children's Hospital — Lexington, Kentucky, United States (enrolling)
• Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States (enrolling)
• Sidney & Lois Eskenazi Hospital — Indianapolis, Indiana, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• University of Utah Health — Salt Lake City, Utah, United States
• University of Vermont Medical Center — Burlington, Vermont, United States
• ChristianaCare — Wilmington, Delaware, United States
• University of Louisville Hospital — Jeffersonville, Indiana, United States
• St. Elizabeth Healthcare — Edgewood, 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 Rochester Medical Center — Rochester, New York, United States
• Good Samaritan Hospital — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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