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Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

NCT02768844 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-03-20

No results posted yet for this study

Summary

The overall purpose of this project is to to quantify the physiology of neonatal drug withdrawal and develop non-pharmacological techniques to help improve the therapeutic management of Neonatal Abstinence Syndrome (NAS).

Conditions

  • Neonatal Abstinence Syndrome

Interventions

DEVICE

Stochastic Vibrotactile Stimulation (SVS)

The infant's isolette mattress will be replaced with a specially designed mattress (non-commercially available; designed by Wyss Institute, Harvard University, Cofab Design LLC) to provide gentle vibrations and sounds during mattress stimulations.

OTHER

Control

Absence of mattress Stochastic Vibratory Stimulation (SVS)

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Elisabeth B Salisbury, Ph.D. · University of Massachusetts, Worcester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-01-23
Completion
2019-12-15
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 NCT02768844 on ClinicalTrials.gov