Health and Neurodevelopmental Outcomes in Infants at Risk for Neonatal Opioid Withdrawal Syndromes: (NOWSEffects of Timing and Duration of Prenatal Opioid Exposure (POE) & Postnatal Management with Eat-Sleep-Console (ESC)

In alignment with the objectives of the FDA to apply regulatory science to ensure optimal drug safety in pediatric populations, this study will address the critical public health consequences of prenatal opioid exposure during the ongoing opioid epidemic in the US. The study will compare differences in outcomes (both in-hospital and neurodevelopmental outcomes) between pharmacotherapy of opioid replacement and non-pharmacological management in infants with prenatal opioid exposure (POE), who are at risk for neonatal opioid withdrawal syndrome (NOWS).

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