Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome (NCT07278375) | Clinical Trial Compass
RecruitingNot Applicable
Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
United States796 participantsStarted 2025-12-09
Plain-language 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?
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.
Who can participate
Age range
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Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time from birth until infant meets criteria for medically ready for discharge (count)
Timeframe: From date of birth until date of infant meeting criteria for medically ready for discharge (estimated to be < 90 days).
. Infant met all inclusion criteria on or after March 25, 2024.
Exclusion criteria
. 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.