Status:
ACTIVE_NOT_RECRUITING
Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach
Lead Sponsor:
HELP for NOWS Consortium
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Neonatal Opiate Withdrawal Syndrome
Eligibility:
All Genders
1-48 years
Phase:
PHASE3
Brief Summary
This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have tremors, a hard time sleeping, exc...
Detailed Description
This two-period cluster crossover clinical trial will compare the length of time from birth until medically ready for discharge between infants with neonatal opioid withdrawal syndrome (NOWS) who are ...
Eligibility Criteria
Inclusion
- The infant is greater than or equal to 36 weeks gestation.
- The infant had antenatal opioid exposure identified by at least one of the following:
- History of maternal opioid use during pregnancy;
- 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 FNAST or modification thereof
- At least 1 "yes" if assessed and managed with the ESC care approach
Exclusion
- The infant has major birth defect(s).
- The 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.
- The infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
- The infant has undergone major surgical intervention prior to or at 48 hours of age.
- The infant has postnatal opioid exposure prior to the initiation of treatment for NOWS.
- The infant was outborn and pharmacologic treatment was initiated at the transferring hospital.
- The infant is assessed for eligibility during the study site's three-week washout period.
Key Trial Info
Start Date :
March 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 27 2025
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT05980260
Start Date
March 25 2024
End Date
August 27 2025
Last Update
July 2 2025
Active Locations (23)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
ChristianaCare
Wilmington, Delaware, United States, 19801
4
University of South Florida Health
Tampa, Florida, United States, 33606