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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

Brief 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.

Detailed Summary:

This study will test the therapeutic efficacy of stochastic vibrotactile stimulation (SVS) for reducing withdrawal symptoms, pharmacological requirement and hospitalization, and for improving neurobehavioral developmental outcomes in opioid-exposed newborns.

Candidates at-risk for NAS due opioid exposure in utero will be identified to investigators by medical caregiver and/or prescreened using HIPAA Waiver for recruitment (maternal-prenatal; infant-postnatal). Infants will be randomized into either SVS (complementary to standard of care) or Standard Clinical Care (SCC), restricted by equipment (mattress) availability. Infants will be enrolled within 24 hours post birth and participate throughout hospitalization. Infants assigned SVS will receive daily intervention of continuous SVS throughout hospitalization using a specially constructed crib mattress that delivers gentle vibrations at preset intervals.

Specific Aim 1. Determine the efficacy of SVS as a non-pharmacological therapy complementary to standard clinical care (SCC) for reducing severity and duration of opioid withdrawal in newborns compared to SCC alone. Quantify clinical variables: NAS severity, days in hospital, velocity of weight gain, cumulative morphine dose.

Specific Aim 2. Compare neurobehavioral outcomes in fetal drug-exposed infants between infants who received SVS and those who received SCC. Longitudinal outcomes assessment at 1 month, 6-months and 1 year to test whether early intervention with SVS compared to standard care improves physical, social, emotional and cognitive development.


Sponsor: University of Massachusetts, Worcester

Current Primary Outcome:

  • Severity of Symptoms [ Time Frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days ]
    Trajectory of mean and max Finnegan withdrawal score throughout hospitalization
  • One Year Neurobehavioral Outcomes Assessment [ Time Frame: Participants will be assessed at 1 mo, 6 mo, and 12 mo ]
    Neurobehavioral battery of outcome assessments


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacological Requirement [ Time Frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days ]
    Cumulative morphine dose
  • Movement Activity [ Time Frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days ]
    Actigraphy (limb movement activity) will be assessed daily throughout hospitalization
  • Velocity of weight gain [ Time Frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days ]
    Trajectory of weight gain throughout hospitalization
  • Hospitalization length of stay [ Time Frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days ]
    Duration of infant hospitalization, which is an expected mean of 21 days


Original Secondary Outcome: Same as current

Information By: University of Massachusetts, Worcester

Dates:
Date Received: June 9, 2016
Date Started: March 9, 2017
Date Completion: July 2021
Last Updated: March 12, 2017
Last Verified: March 2017