Screening Data in Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

Screening information
Study Description
ACT NOW Weaning Trial was a pragmatic, randomized, blinded trial conducted to compare a rapid-wean intervention (15% decrements from the stabilization dose) with a slow-wean intervention (10% decrements from the stabilization dose) to determine whether rapid weaning reduces the number of treatment days among infants receiving morphine or methadone orally as the primary treatment for Neonatal Opioid Withdrawal Syndrome (NOWS). Hospitals could change use of these opioids during trial period. Randomization was stratified by hospital. Study protocol commenced after NOWS signs were controlled with an opioid (stabilization) and weaning of pharmacologic treatment was to be started. At or before each 24-hour interval, clinical team members evaluated and scored infants, per hospital practice, for signs of NOWS to determine if infant would tolerate weaning of study drug. After study drug cessation, clinical team observed infants for at least 48 hours prior to discharge. A trained examiner administered the NeoNatal Neurobehavioral Scale, 2nd edition (NNNS-II) to assess neurobehavioral profiles after ceasing study drug prior to discharge. Newborns with a post-menstrual age ≥ 36 weeks gestation and receiving morphine or methadone as the primary treatment for NOWS among 23 US hospitals.