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Comparing buprenorphine and morphine for newborn opioid withdrawal recovery

Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

Observational HELP for NOWS Consortium · NCT07278375

This study will compare buprenorphine and morphine to see if one helps newborns (born at or after 36 weeks) with neonatal opioid withdrawal recover and become ready to go home sooner.

Quick facts

Study typeObservational
Enrollment796 (estimated)
Ages0 Minutes and up
SexAll
SponsorHELP for NOWS Consortium Research network
Locations22 sites (Birmingham, Alabama and 21 other locations)
Trial IDNCT07278375 on ClinicalTrials.gov

What this trial studies

This is an observational, multi-center analysis that reviews existing medical records from about 22 U.S. hospitals to compare outcomes for infants treated with buprenorphine versus morphine for NOWS. The study will include roughly 796 infants born at 36 weeks' gestation or later who received one of these medications as part of routine care. Researchers will use target trial emulation and advanced statistical methods to adjust for differences between infants and hospitals so the comparison approximates a randomized comparison. No new treatments, visits, or contact with families are required because only recorded clinical data are used.

Who should consider this trial

Good fit: Newborns born at 36 weeks' gestation or later with documented prenatal opioid exposure who were managed for NOWS and at risk for pharmacologic treatment are the ideal candidates for inclusion.

Not a fit: Preterm infants born before 36 weeks, babies without documented opioid exposure, or infants cared for outside the participating hospitals may not benefit directly from this study's findings.

Why it matters

Potential benefit: If one medication is associated with faster readiness for discharge or better clinical outcomes, clinicians could adopt that approach to shorten hospital stays and improve recovery for affected newborns.

How similar studies have performed: Smaller randomized and observational studies have suggested buprenorphine may reduce treatment duration compared with morphine, but evidence remains limited and not definitive.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Infant is ≥ 36 weeks' gestational age
2. Infant had antenatal opioid exposure identified by at least one of the following:

   1. 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;
   2. Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or
   3. Positive infant toxicology screen for opioids during the initial hospital stay.
3. The infant is being assessed and managed for NOWS at an eligible study site.
4. 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
5. Infant met all inclusion criteria on or after March 25, 2024.

Exclusion Criteria:

1. Infant has major congenital anomalies.
2. 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.
3. Infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
4. Infant has undergone major surgical intervention prior to or at 48 hours of age.
5. Infant has postnatal opioid exposure prior to the initiation of pharmacologic treatment for NOWS.
6. Infant was outborn and pharmacologic treatment was initiated at the transferring hospital.

Where this trial is running

Birmingham, Alabama and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neonatal Opioid Withdrawal SyndromeNOWS
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.