In-Hospital Status in Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

Discharge or transfer information and infant characteristics at that time.
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.

出院或转院信息及当时的婴儿特征。
研究描述
ACT NOW减量试验是一项务实、随机、盲法试验，旨在对比快速减量干预（从稳定剂量下调15%）与缓慢减量干预（从稳定剂量下调10%），以明确快速减量是否能缩短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）一线治疗方案的婴儿的治疗时长。试验期间各医院可调整此类阿片类药物的使用方案。随机分组按医院进行分层。研究方案在婴儿的NOWS症状经阿片类药物控制（即达到稳定状态）后启动，并开始药物治疗的减量流程。每24小时周期内或周期前，临床团队成员按照医院的临床规范，对婴儿的NOWS症状进行评估与评分，以判断婴儿是否能够耐受研究药物的减量。研究药物停用后，临床团队需在婴儿出院前对其进行至少48小时的观察。由经过培训的评估人员在研究药物停用后、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。本研究纳入美国23家医院中，胎龄校正后年龄≥36周、且以吗啡或美沙酮作为NOWS一线治疗方案的新生儿。