Status:
COMPLETED
Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
Lead Sponsor:
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Neonatal Opiate Withdrawal Syndrome
Eligibility:
All Genders
Up to 3 years
Phase:
NA
Brief Summary
The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge.
Detailed Description
This study will randomize institutions in blocks to transition from usual institutional care for infants with NOWS to the ESC care approach at a randomly allocated transition period (from usual care t...
Eligibility Criteria
Inclusion
- 1\. The infant is being managed for NOWS at an eligible site (i.e., receiving non-pharmacologic care, assessments for withdrawal severity, +/- pharmacologic care) 2. The infant is ≥ 36 weeks gestation 3. The infant satisfies at least 1 of the following criteria:
- Maternal history of prenatal opioid use
- Maternal toxicology screen positive for opioids during the second and/or third trimester of pregnancy
- Infant toxicology screen positive for opioids during the initial hospital stay
Exclusion
- 1\. Infant has major birth defect(s) 2. Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed by 60 hours of life 3. Infant was receiving respiratory support (any positive pressure or oxygen therapy) unrelated to pharmacologic treatment for NOWS at 60 hours of life 4. Infant was receiving antimicrobial(s) at 60 hours of life 5. Infant has received any major surgical intervention in the first 60 hours of life 6. Postnatal opioid exposure other than for treatment of NOWS in the first 60 hours of life 7. Outborn infants transferred at \>60 hours of life or treated with opioids for NOWS at the transferring hospital
Key Trial Info
Start Date :
September 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2024
Estimated Enrollment :
1305 Patients enrolled
Trial Details
Trial ID
NCT04057820
Start Date
September 8 2020
End Date
September 24 2024
Last Update
February 14 2025
Active Locations (26)
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1
Chistiana Care Health Systems
Newark, Delaware, United States, 19718
2
Tampa General Hospital
Tampa, Florida, United States, 33606
3
Kapiolani Hospital
Honolulu, Hawaii, United States, 96826
4
Kansas University Medical Center
Kansas City, Kansas, United States, 66160