Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
TreaT NOW
10 other identifiers
observational
796
1 country
22
Brief Summary
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
Shorter than P25 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2025
CompletedStudy Start
First participant enrolled
December 9, 2025
CompletedFirst Posted
Study publicly available on registry
December 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2026
February 25, 2026
February 1, 2026
6 months
November 21, 2025
February 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time from birth until infant meets criteria for medically ready for discharge (count)
Number of days from birth until infant meets criteria for medically ready for discharge. An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet both of the following criteria: * 96 hours of age * 48 hours since last dose of treatment with morphine or buprenorphine
From date of birth until date of infant meeting criteria for medically ready for discharge (estimated to be < 90 days).
Secondary Outcomes (8)
Length of hospital stay (count)
From date of birth until date of hospital discharge (estimated to be < 90 days).
Length of primary opioid treatment (count)
From date of birth until date of last primary opioid dose administration (estimated to be < 90 days).
Number of primary opioid doses administered (count)
From date of birth until date of last primary opioid dose administration (estimated to be < 90 days).
Receipt of secondary medication (binary)
From date of birth until date of first non-opioid secondary medication administration or until date of hospital discharge, whichever comes first (estimated to be < 90 days).
Inpatient composite safety outcome (binary)
From date of birth until date of first occurrence of seizure or excessive weight loss more than 15% from birthweight or until date of last primary opioid dose administration, whichever comes first (estimated to be < 90 days).
- +3 more secondary outcomes
Study Arms (2)
Infants treated with buprenorphine
Infants treated with buprenorphine as the primary opioid for NOWS
Infants treated with morphine
Infants treated with morphine as the primary opioid for NOWS
Eligibility Criteria
The study population will include infant and mother dyads who fulfill the study inclusion and exclusion criteria.
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
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205-7199, United States
ChristianaCare
Wilmington, Delaware, 19801, United States
University of South Florida Health
Tampa, Florida, 33606, United States
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202-5119, United States
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
University of Louisville Hospital
Jeffersonville, Indiana, 47130, United States
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
Kentucky Children's Hospital
Lexington, Kentucky, 40536, United States
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
Norton Women's and Children's Hospital
Louisville, Kentucky, 40207, United States
Children's Regional Hospital, Cooper University Health Care
Camden, New Jersey, 08103, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45202, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
University of Utah Health
Salt Lake City, Utah, 84158, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Related Links
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 90 Days
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2025
First Posted
December 12, 2025
Study Start
December 9, 2025
Primary Completion (Estimated)
June 19, 2026
Study Completion (Estimated)
August 30, 2026
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Within 1 year of study completion.
Data collected for this study will be analyzed and stored at the DCC, RTI International. NIH Helping to End Addiction Long-term Initiative (HEAL) and NICHD requirements for data-sharing will apply. NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. In accordance with these policies (available at HEAL Public Access and Data Sharing \| NIH HEAL Initiative), we will share de-identified data collected for the study. After the study is completed, the de-identified, archived data will be transmitted to a NIH HEAL supported repository, for use by other researchers including those outside of the study.