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

Inclusion 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 thefollowing:

• History of maternal opioid use during pregnancy;

• Positive maternal toxicology screen for opioids during the second or thirdtrimester 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 thefollowing

• 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 Criteria:

1. The infant has major birth defect(s).

2. The infant has neonatal encephalopathy (inclusive of hypoxic ischemicencephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, ormeningitis diagnosed prior to the initiation of pharmacologic treatment.

3. The infant is receiving respiratory support (any positive pressure or oxygentherapy) 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 forNOWS.

6. The infant was outborn and pharmacologic treatment was initiated at the transferringhospital.

7. The infant is assessed for eligibility during the study site's three-week washoutperiod.