Bloch-Salisbury Elisabeth, Bogen Debra, Vining Mark, Netherton Dane, Rodriguez Nicolas, Bruch Tory, Burns Cheryl, Erceg Emily, Glidden Barbara, Ayturk Didem, Aurora Sanjay, Yanowitz Toby, Barton Bruce, Beers Sue
Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, 01655, USA.
Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA, 15213, USA.
Contemp Clin Trials Commun. 2021 Feb 11;21:100737. doi: 10.1016/j.conctc.2021.100737. eCollection 2021 Mar.
The incidence of Neonatal Abstinence Syndrome (NAS) continues to rise and there remains a critical need to develop non-pharmacological interventions for managing opioid withdrawal in newborns. Objective physiologic markers of opioid withdrawal in the newborn remain elusive. Optimal treatment strategies for improving short-term clinical outcomes and promoting healthy neurobehavioral development have yet to be defined. This dual-site randomized controlled trial (NCT02801331) is designed to evaluate the therapeutic efficacy of stochastic vibrotactile stimulation (SVS) for reducing withdrawal symptoms, pharmacological treatment, and length of hospitalization, and for improving developmental outcomes in opioid-exposed neonates. Hospitalized newborns (n = 230) receiving standard clinical care for prenatal opioid exposure will be randomly assigned within 48-hours of birth to a crib with either: 1) Intervention (SVS) mattress: specially-constructed SVS crib mattress that delivers gentle vibrations (30-60 Hz, ~12 μm RMS surface displacement) at 3-hr intervals; or 2) Control mattress (treatment as usual; TAU): non-oscillating hospital-crib mattress. Infants will be studied throughout their hospitalization and post discharge to 14-months of age. The study will compare clinical measures (i.e., withdrawal scores, cumulative dose and duration of medications, velocity of weight gain) and characteristic progression of physiologic activity (i.e., limb movement, cardio-respiratory, temperature, blood-oxygenation) throughout hospitalization between opioid-exposed infants who receive SVS and those who receive TAU. Developmental outcomes (i.e., physical, social, emotional and cognitive) within the first year of life will be evaluated between the two study groups. Findings from this randomized controlled trial will determine whether SVS reduces in-hospital severity of NAS, improves physiologic function, and promotes healthy development.
新生儿戒断综合征（NAS）的发病率持续上升，因此迫切需要开发非药物干预措施来管理新生儿的阿片类药物戒断。新生儿阿片类药物戒断的客观生理指标仍然难以捉摸。改善短期临床结果和促进健康神经行为发育的最佳治疗策略尚未确定。这项双中心随机对照试验（NCT02801331）旨在评估随机振动触觉刺激（SVS）在减轻戒断症状、药物治疗和住院时间方面的治疗效果，以及对阿片类药物暴露新生儿发育结果的改善情况。因产前阿片类药物暴露而接受标准临床护理的住院新生儿（n = 230）将在出生后48小时内随机分配到配备以下两种床垫之一的婴儿床中：1）干预（SVS）床垫：特制的SVS婴儿床床垫，每隔3小时提供一次轻柔振动（30 - 60赫兹，均方根表面位移约12微米）；或2）对照床垫（常规治疗；TAU）：不振动的医院婴儿床床垫。婴儿将在整个住院期间以及出院后至14个月大时接受研究。该研究将比较接受SVS的阿片类药物暴露婴儿和接受TAU的婴儿在住院期间的临床指标（即戒断评分、药物累积剂量和持续时间、体重增加速度）以及生理活动的特征进展（即肢体运动、心肺功能、体温、血氧饱和度）。两个研究组将评估生命第一年的发育结果（即身体、社交、情感和认知方面）。这项随机对照试验的结果将确定SVS是否能降低NAS的院内严重程度、改善生理功能并促进健康发育。
