NCT07278375 Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
| NCT ID | NCT07278375 |
| Status | Recruiting |
| Phase | — |
| Sponsor | HELP for NOWS Consortium |
| Condition | Neonatal Opioid Withdrawal Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 796 participants |
| Start Date | 2025-12-09 |
| Primary Completion | 2026-06-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 796 participants in total. It began in 2025-12-09 with a primary completion date of 2026-06-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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? 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07278375 clinical trial?
This trial is open to participants of all sexes, aged 0 Minutes or older, studying Neonatal Opioid Withdrawal Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07278375 currently recruiting?
Yes, NCT07278375 is actively recruiting participants. Contact the research team at Walter.Kraft@jefferson.edu for enrollment information.
Where is the NCT07278375 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Wilmington, United States, Tampa, United States and 11 additional locations.
Who is sponsoring the NCT07278375 clinical trial?
NCT07278375 is sponsored by HELP for NOWS Consortium. The trial plans to enroll 796 participants.