Study design and rationale for a randomized controlled trial to assess effectiveness of stochastic vibrotactile mattress stimulation versus standard non-oscillating crib mattress for treating hospitalized opioid-exposed newborns.
Study design and rationale for a randomized controlled trial to assess effectiveness of stochastic vibrotactile mattress stimulation versus standard non-oscillating crib mattress for treating hospitalized opioid-exposed newborns.
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随机对照试验的研究设计和原理，以评估随机振动触觉床垫刺激与标准非振荡婴儿床床垫治疗住院阿片类药物暴露新生儿的有效性。
DOI：
10.1016/j.conctc.2021.100737
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发表时间：
2021-03
影响因子：
1.5
通讯作者：
Beers S
中科院分区：
文献类型：
--
作者：
Bloch-Salisbury E;Bogen D;Vining M;Netherton D;Rodriguez N;Bruch T;Burns C;Erceg E;Glidden B;Ayturk D;Aurora S;Yanowitz T;Barton B;Beers S
新生儿戒断综合征（NAS）的发病率继续上升，仍然迫切需要开发非药物干预措施来管理新生儿的阿片类戒断。新生儿阿片类药物戒断的客观生理标志物仍然难以捉摸。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（NCT 02801331）旨在评价随机振动触觉刺激（SVS）在减少阿片类药物暴露新生儿戒断症状、药物治疗和住院时间以及改善发育结局方面的疗效。因产前阿片类药物暴露接受标准临床护理的住院新生儿（n = 230）将在出生后48小时内随机分配到带有以下任一项的婴儿床：1）干预（SVS）床垫：提供轻微振动的特殊构造SVS婴儿床床垫（30-60 Hz，~12 μm RMS表面位移）;或2）对照床垫（照常治疗; TAU）：非振荡医院婴儿床床垫。将在婴儿住院期间和出院后至14个月龄期间对婴儿进行研究。该研究将比较临床指标（即，戒断评分、药物的累积剂量和持续时间、体重增加的速度）和生理活动的特征性进展（即，肢体运动、心肺功能、体温、血氧饱和度）。发展成果（即，将对两个研究组在生命第一年内的身体、社会、情感和认知能力）进行评估。这项随机对照试验的结果将确定SVS是否能降低NAS的住院严重程度，改善生理功能，促进健康发育。
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.
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