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Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome

NCT02801331 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2025-06-11

Study results available
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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.

Conditions

  • Neonatal Abstinence Syndrome

Interventions

DEVICE

Stochastic Vibrotactile Stimulation (SVS)

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

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Massachusetts, Worcester

    collaborator OTHER

  • Elisabeth B Salisbury

    lead OTHER

Principal Investigators

  • Elisabeth B Salisbury, Ph.D. · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2021-03-05
Completion
2021-06-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02801331 on ClinicalTrials.gov