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.
Drug withdrawal in newborns due to drug exposure during pregnancy is a growing and costly public health problem, and increasingly more infants are spending their first weeks of life in the hospital for treatment of serious withdrawal, which can be life threatening. There is a critical need to develop non-pharmacological interventions for managing withdrawal in newborns to reduce symptoms, facilitate weaning, decrease pharmacotherapy, and provide additional intervention for infants in whom pharmacological treatment is insufficient. We will study whether a specially-constructed crib mattress that delivers gentle vibrations has potential as a therapeutic treatment for opioid-exposed newborns to reduce symptoms and minimize hospitalization, with implications for better regulation of systems, improved developmental outcomes and reduced medical costs.
|Zuzarte, Ian; Indic, Premananda; Barton, Bruce et al. (2017) Vibrotactile stimulation: A non-pharmacological intervention for opioid-exposed newborns. PLoS One 12:e0175981|