Buprenorphine vs. MorphineTarget Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

Inclusion Criteria:

1. Infant is ≥ 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 ≥ 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.