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โ† Trials
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Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

Recruitingn/aAges 0 Minutes - anyAllHELP for NOWS Consortium
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to learn how two medicines used in routine care-buprenorphine and morphine-affect recovery in newborns (โ‰ฅ36 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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Infant is โ‰ฅ 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 โ‰ฅ 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.
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What it tests

  • Not listed
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Where

22 sites
University of Alabama at Birmingham
Birmingham, United States
University of Arkansas for Medical Sciences
Little Rock, United States
ChristianaCare
Wilmington, United States
University of South Florida Health
Tampa, United States
Riley Hospital for Children at IU Health
Indianapolis, United States
Sidney & Lois Eskenazi Hospital
Indianapolis, United States
University of Louisville Hospital
Jeffersonville, United States
St. Elizabeth Healthcare
Edgewood, United States

โ€ฆand 14 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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