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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-09

Study Completion Date

2021-06-06

Brief Summary

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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.

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Detailed Description

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This study will test the therapeutic efficacy of stochastic vibrotactile stimulation (SVS) for reducing withdrawal symptoms, pharmacological treatment 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 Treatment as Usual (TAU), restricted by equipment (mattress) availability. Infants will be enrolled and assigned to a condition within 48 hours post birth and participate throughout hospitalization. Infants assigned SVS will receive daily intervention of continuous intervals of 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 of care for reducing severity and duration of opioid withdrawal in newborns compared to TAU alone. Quantify clinical variables: NAS severity, treatment days, 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 TAU. Longitudinal outcomes assessment at 6-months and 1 year to test whether early intervention with SVS compared to standard care improves physical, social, emotional and cognitive development.

Conditions

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Neonatal Abstinence Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Stochastic Vibrotactile Stimulation (SVS)

Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).

Group Type EXPERIMENTAL

Stochastic Vibrotactile Stimulation (SVS)

Intervention Type DEVICE

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

Treatment as Usual (TAU)

Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Full-term infants (≥37 wks gestational age)
* Newborns at risk for NAS due to opioid-exposure in utero
* At-risk infants will be infants who present with confirmed meconium and/or urine toxicology report and/or documented medical record for opioids (e.g., methadone, buprenorphine/subutex, oxycodone, heroin); may also have prenatal exposure to benzodiazepines, barbiturates, amphetamines, cannabinoids, alcohol, nicotine and/or caffeine.

* Born less than \<37weeks.
* Has a clinically significant congenital abnormality
* Has a clinically significant fetal anomaly
* Has hydrocephalus or intraventricular hemorrhage \>grade 2
* Has a seizure disorder not related to drug withdrawal
* Has a clinically significant cardiac shunt
* Has anemia (hemoglobin\<8g/dL)
* Requires mechanical respiratory support
* Has MRSA or infection at time of the study

Minimum Eligible Age

1 Hour

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No