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
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Publisher version
UMass Chan Affiliations
Department of Population and Quantitative Health SciencesDepartment of Pediatrics
Document Type
Journal ArticlePublication Date
2021-02-11Keywords
Developmental outcomesEMR
Electronic Medical Record
Infant drug withdrawal
Maternal substance use during pregnancy
NAS
Neonatal Abstinence Syndrome
NICU
Neonatal Intensive Care Unit
NNNewborn NurseryNeonatal abstinence syndromeNeonatal opioid withdrawal syndromeSVSStochastic vibrotactile stimulation (intervention-mattress condition)Stochastic resonanceTAUTreatment as usual (control condition)UMassUMass Memorial Healthcare (Coordinating/Primary study site)UPittUniversity of Pittsburgh (Consortium study site)Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesPediatricsSubstance Abuse and Addiction
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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 mum 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.Source
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. 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. Contemp Clin Trials Commun. 2021 Feb 11;21:100737. doi: 10.1016/j.conctc.2021.100737. PMID: 33748529; PMCID: PMC7960539. Link to article on publisher's site
DOI
10.1016/j.conctc.2021.100737Permanent Link to this Item
http://hdl.handle.net/20.500.14038/29743PubMed ID
33748529Related Resources
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Copyright © 2021 The Authors. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).Distribution License
http://creativecommons.org/licenses/by-nc-nd/4.0/Scopus Count
Except where otherwise noted, this item's license is described as Copyright © 2021 The Authors. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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