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

随机振动触觉刺激：新生儿戒断和戒毒的非药物干预

• 批准号: 10320587
• 负责人: Elisabeth Bloch Salisbury
• 金额: $ 31.41万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10320587
• 关键词: Stochastic; vibro; tactile; stimulation; non

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.

总结/摘要 新生儿药物戒断是一个日益严重且代价高昂的公共卫生问题。婴儿接触药物期间 妊娠通常需要长期住院治疗，并对中枢神经系统、自主神经系统、血管和 胃肠道不稳定，这可能导致不良的神经行为结果。迫切需要 制定非药物干预措施，用于管理新生儿戒断，以减少戒断 症状，促进断奶，减少药物治疗，并为婴儿提供额外的干预， 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、大脑发育和功能稳定的刺激，以及 改善与宫内药物暴露有关的行为。有证据表明，低水平，随机 （随机）刺激可以促进不稳定的生物系统的稳定性，包括改善转导 皮肤机械感受器的动物，在成人的感觉知觉，并改善心肺 在早产儿中的作用我们最近的试点数据表明，低水平随机的急性表现 振动刺激（SVS）通过一个弹性结构的婴儿床床垫传递， 在戒毒婴儿中的作用。这项建议的主要目的是测试早期干预是否 （出生后24小时内开始）和每日给予SVS减少了戒断症状， 神经行为结果。这项研究的结果将阐明SVS是否有潜力作为治疗 治疗接触药物的新生儿，以减少中毒，促进断奶， 住院治疗，对更好地调节系统，改善发展成果， 降低医疗费用。 该项目将调查的三个领域是： 1.确定SVS作为标准补充的非药物治疗的疗效 临床护理（SCC），以减少新生儿阿片类药物戒断的严重程度和持续时间， 单独的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.检查在戒断严重程度的不同阶段对SVS的生理反应， SCC。测量心肺稳定性、体温调节、运动作为睡眠指标 分裂，唾液皮质醇作为应激水平的指标。 3.比较暴露于药物的胎儿婴儿与接受药物的婴儿的神经行为结果 SVS和接受SCC的患者。1个月、6个月和1年时的纵向结局评估， 测试与标准护理相比，SVS的早期干预是否改善了身体、社会、情感和 认知发展

项目成果

Physiologic dysregulation in newborns with prenatal opioid exposure: Cardiac, respiratory and movement activity.

• DOI: 10.1016/j.ntt.2022.107105
• 发表时间: 2022-07
• 期刊: Neurotoxicology and teratology
• 影响因子: 2.9
• 作者: Bloch-Salisbury E;Rodriguez N;Bruch T;McKenna L;Goldschmidt L
• 通讯作者: Goldschmidt L

Actigraphy: An Adjunctive Method to Measure Irritability in Opioid-Exposed Newborns.

体动记录仪：测量阿片类药物暴露新生儿烦躁性的辅助方法。

• DOI: 10.1891/jnm-2023-0020
• 发表时间: 2023
• 期刊: Journal of nursing measurement
• 影响因子: 0.7
• 作者: Liu,VivianY;Flahive,JulieM;Bloch-Salisbury,Elisabeth
• 通讯作者: Bloch-Salisbury,Elisabeth

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.

• DOI: 10.1016/j.conctc.2021.100737
• 发表时间: 2021-03
• 期刊: Contemporary clinical trials communications
• 影响因子: 1.5
• 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
• 通讯作者: Beers S