Evidence map›Paper›PMID 33748529›Full record

ArticleContemporary clinical trials communications2021

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 and 4 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02801331 (A Randomized Controlled Study of Stochastic Vibrotactile Stimulation for Neonatal Abstinence Syndrome), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 45% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02801331 nacompletednot on this map

A Randomized Controlled Study of Stochastic Vibrotactile Stimulation for Neonatal Abstinence Syndrome: Therapeutic Efficacy and Neurobehavioral Outcomes

TypeinterventionalSponsorElisabeth B SalisburyRan2017 to 2021Enrolled208ConditionsNeonatal Abstinence SyndromeArmsStochastic Vibrotactile Stimulation (SVS)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 3 institutions in 1 country.

Elisabeth Bloch-SalisburyDepartment of Pediatrics, University of Massachusetts Medical School, Worcester, MA, 01655, USA.
Debra BogenDepartment of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA, 15213, USA.
Mark ViningDepartment of Pediatrics, University of Massachusetts Medical School, Worcester, MA, 01655, USA.
Dane NethertonDepartment of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, 01655, USA.
Nicolas RodriguezDepartment of Pediatrics, University of Massachusetts Medical School, Worcester, MA, 01655, USA.
Tory BruchDepartment of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA, 15213, USA.
Cheryl BurnsUniversity of Pittsburgh Medical Center, Pittsburgh, PA, 15213, USA.
Emily ErcegUniversity of Pittsburgh Medical Center, Pittsburgh, PA, 15213, USA.
Barbara GliddenDepartment of Pediatrics, University of Massachusetts Medical School, Worcester, MA, 01655, USA.
Didem AyturkDepartment of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, 01655, USA.
Sanjay AuroraDepartment of Pediatrics, University of Massachusetts Medical School, Worcester, MA, 01655, USA.
Toby YanowitzDepartment of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA, 15213, USA.
Bruce BartonDepartment of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, 01655, USA.
Sue BeersDepartment of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, 15213, USA.
University of Massachusetts Chan Medical School · USUniversity of Pittsburgh · USUniversity of Pittsburgh Medical Center · US

Funding

Stochastic vibro-tactile stimulation: A non-pharmacological intervention for abstinence and drug withdrawal in newborn infantsR01DA042074 · NIDA · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI SALISBURY, ELISABETH BLOCH · 2016 to 2020
$3.1M
NIDA NIH HHS R01 DA042074
6 · The paper itself

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.

Indexed as

Developmental outcomesEMR, Electronic Medical RecordInfant drug withdrawalMaternal substance use during pregnancyNAS, Neonatal Abstinence SyndromeNeonatal abstinence syndromeNeonatal opioid withdrawal syndromeNICU, Neonatal Intensive Care UnitNN, Newborn NurseryStochastic resonanceSVS, Stochastic vibrotactile stimulation (intervention-mattress condition)TAU, Treatment as usual (control condition)UMass, UMass Memorial Healthcare (Coordinating/Primary study site)UPitt, University of Pittsburgh (Consortium study site)

Identifiers

PMID33748529
PMCPMC7960539
OpenAlexW3129641901

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.