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: 9319658
• 负责人: Elisabeth Bloch Salisbury
• 金额: $ 60.58万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9319658
• 关键词: Abstinence; Acute; Address; Adult; Animals; Area; Behavior; Behavioral; Biological Markers; Birth; Brain; Clinical; Cognitive; Complementary therapies; Cutaneous; Data; Development; Dose; Drug Exposure; Early Intervention; Effectiveness; Emotional; Healthcare; Hospitalization; Hospitals; Hour; Hydrocortisone; Impairment; Infant; Intervention; Life; Longitudinal prospective study; Massachusetts; Mattresses; Measures; Mechanoreceptors; Medical; Medication Management; Morbidity - disease rate; Morphine; Motor Activity; Movement; Neonatal; Neonatal Abstinence Syndrome; Newborn Infant; Noise; Opioid; Outcome; Outcome Assessment; Perception; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Physiological; Physiology; Population; Pregnancy; Premature Infant; Public Health; Randomized Controlled Trials; Regulation; Research; Research Personnel; Rosa; Salivary; Sensory; Severities; Site; Sleep Fragmentations; Stress; Symptoms; System; Tactile; Temperature; Testing; Therapeutic; Therapeutic Intervention; Time; Universities; Vasomotor; Weaning; Weight Gain; Withdrawal; Withdrawal Symptom; biological systems; brief intervention; clinical care; cognitive development; cognitive function; cost; critical period; demographics; drug withdrawal; emotional adjustment; fetal; follow-up; gastrointestinal; group intervention; improved; in utero; indexing; innovation; neonate; neurobehavioral; novel; opioid withdrawal; reduce symptoms; response; social; standard care; standard of care; symptomatology; vibration

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.

摘要/文摘