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

Elisabeth Bloch-Salisbury, Debra Bogen, Mark Vining, Dane Netherton, Nicolas Rodriguez, Tory Bruch, Cheryl Burns, Emily Erceg, Barbara Glidden, Didem Ayturk, Sanjay Aurora, Toby Yanowitz, Bruce Barton, Sue Beers, Elisabeth Bloch-Salisbury, Debra Bogen, Mark Vining, Dane Netherton, Nicolas Rodriguez, Tory Bruch, Cheryl Burns, Emily Erceg, Barbara Glidden, Didem Ayturk, Sanjay Aurora, Toby Yanowitz, Bruce Barton, Sue Beers

Abstract

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.

Keywords: Developmental outcomes; EMR, Electronic Medical Record; Infant drug withdrawal; Maternal substance use during pregnancy; NAS, Neonatal Abstinence Syndrome; NICU, Neonatal Intensive Care Unit; NN, Newborn Nursery; Neonatal abstinence syndrome; Neonatal opioid withdrawal syndrome; SVS, Stochastic vibrotactile stimulation (intervention-mattress condition); Stochastic resonance; TAU, Treatment as usual (control condition); UMass, UMass Memorial Healthcare (Coordinating/Primary study site); UPitt, University of Pittsburgh (Consortium study site).

Conflict of interest statement

Dr. Bloch-Salisbury is an inventor on a patent (PCT/US2015/021999) licensed to Prapela, Inc related to the SVS-mattress device and is a potential beneficiary of a licensing agreement with Prapela, Inc. The authors have no other financial relationships relevant to this article to disclose.

© 2021 The Authors.

Figures

Fig. 1
Fig. 1
Stochastic vibrotactile stimulation (SVS) mattress device.
Fig. 2
Fig. 2
Target enrollment plan. SVS=Stochastic vibrotactile stimulation mattress (intervention); TAU = Treatment as usual (control).
Fig. 3
Fig. 3
Bedside Setup. SVS group = Infants randomly assigned to receive stochastic vibrotractile stimulation: SVS mattress in bedside portable crib with stimulus driver and uninterrupted power supply in crib-cart shelving; TAU group = Infants randomly assigned to receive treatment as usual (hospital crib mattress, not shown); Touchscreen computerized bedside log with laminated instructions attaches to crib; Mattress protocol indicates automated 3-hour stimulation cycle (SVS) or no stimulation (TAU).

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