CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 208 enrolled
Drug / intervention
Stochastic Vibrotactile Stimulation (SVS)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02801331
NCT02801331N/ACompleted
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A Randomized Controlled Study of Stochastic Vibrotactile Stimulation for Neonatal Abstinence Syndrome: Therapeutic Efficacy and Neurobehavioral Outcomes

Elisabeth B Salisbury·interventional·Posted Jun 15, 2016·Updated Jun 11, 2025

In Brief

A clinical study evaluating Stochastic Vibrotactile Stimulation (SVS) for Neonatal Abstinence Syndrome. Completed, enrolled 208 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the efficacy of a specially-constructed crib mattress that delivers gentle vibrations (stochastic vibrotactile stimulation) as a complementary, non-pharmacological intervention for treating drug withdrawal in newborns exposed to opioids in utero.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Abstinence Syndrome
CountriesUnited States
CollaboratorsUniversity of Pittsburgh, National Institute on Drug Abuse (NIDA), University of Massachusetts, Worcester

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 15, 2016
Enrollment StartMar 9, 2017
Primary CompletionMar 5, 2021
Study CompletionJun 6, 2021
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 10.0 years ago

Interventions

Stochastic Vibrotactile Stimulation (SVS)device

Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.