Stochastic vibro-tactile stimulation: A non-pharmacological intervention for abstinence and drug withdrawal in newborn infants

摘要/摘要 新生儿停药是一个日益严重且代价高昂的公共卫生问题。婴儿在以下情况下接触毒品 怀孕通常需要延长住院时间，并使用药物治疗中枢、自主神经、血管舒缩和 胃肠道不稳定，这可能导致不良的神经行为结果。迫切需要 制定管理新生儿戒断的非药物干预措施，以减少戒断 症状，促进脱机，减少药物治疗，并提供额外的干预 药物治疗不足的患者。越来越多的研究表明感官触觉的重要性 促进生理成熟、脑发育和功能稳定的刺激，以及 与宫内药物暴露有关的行为改善。证据支持这种低水平的、随机的 (随机)刺激可以促进不稳定的生物系统的稳定性，包括改进的转导 动物的皮肤机械感受器、成人的感官知觉和心肺功能的改善 早产儿的功能。我们最近的试点数据表明，低水平随机的急性表现 通过独特构造的婴儿床床垫提供的振动刺激(SVS)改善生理 在戒毒婴儿中的功能。这项提议的主要目标是测试早期干预是否 (在出生后24小时内开始)和每日服用SVS可减少戒断并改善 神经行为结果。这项研究的发现将阐明SVS是否具有治疗的潜力 对接触药物的新生儿进行治疗，减轻症状，促进脱机，最大限度地减少 住院，对更好地调节系统、改善发育结局和 降低了医疗成本。 本项目将调查的三个领域是： 1.确定SVS作为补充标准的非药物疗法的疗效 临床护理(SCC)可降低新生儿阿片类药物戒断的严重程度和持续时间 只有SCC。量化临床变量：NAS严重程度、住院天数、体重增加速度、累积 吗啡剂量。 2.检查戒断严重程度不同阶段对SVS的生理反应 SCC。将心肺稳定性、体温调节、运动作为睡眠指标 碎片、唾液皮质醇作为应激水平的指标。 3.比较胎儿药物暴露婴儿和接受药物治疗的婴儿的神经行为结果 SVS和那些接受SCC的人。在1个月、6个月和1年内进行纵向结果评估 测试与标准护理相比，早期干预SVS是否改善了身体、社交、情绪和 认知发展。

SUMMARY/ABSTRACT Drug withdrawal in newborns is a growing and costly public health problem. Infants exposed to drugs during pregnancy often require prolonged hospitalization with pharmacotherapy for central, autonomic, vasomotor and gastrointestinal instabilities, which may contribute to poor neurobehavioral outcomes. There is a critical need to develop non-pharmacological interventions for managing withdrawal in newborns to reduce withdrawal symptoms, facilitate weaning, decrease pharmacotherapy, and provide additional intervention for infants in whom pharmacological treatment is insufficient. Growing research suggests the importance of sensory tactile stimulation for promoting physiological maturation, brain development, and stability of function, and for improving behaviors implicated in intrauterine drug exposure. Evidence supports that low-level, stochastic (random) stimulation can promote stability in destabilized biological systems, including improved transduction of cutaneous mechanoreceptors in animals, sensory perception in adults, and improved cardio-respiratory function in premature infants. Our recent pilot data suggests that acute presentation of low-level stochastic vibratory stimulation (SVS) delivered through a uniquely-constructed crib mattress improves physiological function in drug-withdrawing infants. The main objective of this proposal is to test whether early intervention (initiated within 24 hours post birth) and daily administration of SVS reduces withdrawal and improves neurobehavioral outcomes. Findings from this study will elucidate whether SVS has potential as a therapeutic treatment for drug-exposed newborns to reduce symptomatology, facilitate weaning and minimize hospitalization, with implications for better regulation of systems, improved developmental outcomes and reduced medical costs. The three areas to be investigated in this project are: 1. Determine the efficacy of SVS as a non-pharmacological therapy complementary to standard clinical care (SCC) for reducing severity and duration of opioid withdrawal in newborns compared to SCC alone. Quantify clinical variables: NAS severity, days in hospital, velocity of weight gain, cumulative morphine dose. 2. Examine physiological responses to SVS at different stages of withdrawal severity compared to SCC. Measure cardio-respiratory stability, temperature regulation, movement as an index of sleep fragmentation, salivary cortisol as an index of stress level. 3. Compare neurobehavioral outcomes in fetal drug-exposed infants between infants who received SVS and those who received SCC. Longitudinal outcomes assessment at 1 month, 6-months and 1 year to test whether early intervention with SVS compared to standard care improves physical, social, emotional and cognitive development.