Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach

Eligibility Criteria

• 1. The infant is greater than or equal to 36 weeks gestation.
• 2. 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.
• 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 FNAST or modification thereof
• * At least 1 "yes" if assessed and managed with the ESC care approach
• 1. The infant has major birth defect(s).
• 2. 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.
• 3. The infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
• 4. The infant has undergone major surgical intervention prior to or at 48 hours of age.
• 5. The infant has postnatal opioid exposure prior to the initiation of treatment for NOWS.
• 6. The infant was outborn and pharmacologic treatment was initiated at the transferring hospital.
• 7. The infant is assessed for eligibility during the study site's three-week washout period.