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

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.

ACT NOW减量戒断试验（ACT NOW Weaning Trial）是一项务实型随机盲法临床试验，旨在对比快速减量干预方案（自稳定剂量下调15%）与慢速减量干预方案（自稳定剂量下调10%），以明确快速减量是否可降低以口服吗啡或美沙酮作为新生儿阿片类药物戒断综合征（Neonatal Opioid Withdrawal Syndrome, NOWS）一线治疗药物的婴儿的治疗天数。试验期间，各参与医院可调整上述阿片类药物的临床使用方案。随机化过程按医院分层实施。
试验方案启动于婴儿的NOWS症状经阿片类药物控制并达到稳定状态后，随即启动研究药物的减量治疗。每24小时周期内或周期前，临床团队将按照本院临床操作规范对婴儿的NOWS症状进行评估与评分，以此判断婴儿是否能够耐受研究药物的减量操作。
在研究药物停用后，临床团队需对婴儿进行至少48小时的临床观察，方可安排出院。一名经过专业培训的评估人员将在研究药物停用后、患儿出院前，采用新生儿神经行为量表第二版（NeoNatal Neurobehavioral Scale, 2nd edition, NNNS-II）对婴儿的神经行为特征进行评估。