Comparing Buprenorphine and Morphine Treatments for Newborns with Neonatal Opioid Withdrawal Syndrome to Understand Recovery and Hospital Stay

What this Trial Is About

This research aims to understand how two common medicines, buprenorphine and morphine, affect recovery in newborns born at or after 36 weeks gestation who have Neonatal Opioid Withdrawal Syndrome NOWS. NOWS occurs in infants exposed to opioids before birth and can cause symptoms like irritability and feeding difficulties. The study compares whether one medicine helps babies become medically ready for discharge faster and leads to better overall outcomes. The study reviews medical records from about 796 infants treated with either buprenorphine or morphine at around 22 hospitals in the United States. Since treatment choices are made by clinical teams during routine care, researchers use advanced methods to fairly compare outcomes between the two medicines. No new treatments, procedures, or visits are involved, and no families are contacted during this observational study. Participants existing clinical data, including birth details, withdrawal symptoms, treatment information, feeding, and clinical outcomes, will be collected securely. The main outcome measured is the time from birth until the infant is medically ready for discharge. Other outcomes include length of hospital stay and safety events. All data are handled confidentially under privacy rules, and the studys findings may help improve future care for infants with NOWS.

Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome