Comparing buprenorphine and morphine for newborn opioid withdrawal recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• University of South Florida Health
  Tampa, Florida, United States Recruiting
• Riley Hospital for Children at IU Health
  Indianapolis, Indiana, United States Recruiting
• Sidney & Lois Eskenazi Hospital
  Indianapolis, Indiana, United States Recruiting
• Kentucky Children's Hospital
  Lexington, Kentucky, United States Recruiting

Study contacts

• Study coordinator: Walter K Kraft, MD
• Email: Walter.Kraft@jefferson.edu
• Phone: 215-955-9077

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brain blood flow and oxygen use in newborns with prenatal opioid exposure

  The study tests a new optical device to see if brain blood flow and oxygen use differ in newborns exposed to opioids before birth compared with unexposed newborns.

  Recruiting Indiana University · Indianapolis, Indiana · NCT07610746

• Identifying microRNA biomarkers for infants with opioid withdrawal

  This study is trying to see if certain tiny molecules in the saliva of newborns exposed to opioids can help predict their treatment needs and development outcomes.

  Recruiting Milton S. Hershey Medical Center · Hershey, Pennsylvania · NCT05937594

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.