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

Study Overview
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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.

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.

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

Conditions
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Neonatal Abstinence Syndrome

Intervention / Treatment
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* Device: Stochastic Vibrotactile Stimulation (SVS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible subjects are infants currently in the NICU or Newborn Nursery at University of Massachusetts Memorial Hospital or at Magee Women's Hospital of UPMC and: 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. Exclusion Criteria: Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she: 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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stochastic Vibrotactile Stimulation (SVS)<br>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). Infants will be scored for severity of withdrawal using standardized, modified Finnegan scoring system by clinical care nurses per routine clinical care throughout hospitalization. | Device: Stochastic Vibrotactile Stimulation (SVS)<br>* Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle vibrations and sounds during mattress stimulations.<br>|
| No Intervention: Treatment as Usual (TAU)<br>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. Infants will be scored for severity of withdrawal using standardized, modified Finnegan scoring system by clinical care nurses per routine clinical care throughout hospitalization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacological Treatment-Dose | Cumulative morphine dose | Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days | 
| Pharmacological Treatment-Duration | Total days of morphine treatment | Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days | 
| Neurobehavioral Outcomes Assessment | Neurobehavioral infant assessment at 6 month followup | Participants will be assessed at approx 1 month, 6 months, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Velocity of weight gain | Trajectory of weight gain throughout hospitalization-Days to return to birth weight | Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days | 
| Hospitalization length of stay | Duration of infant hospitalization | Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stochastic Resonance, Fetus/Newborn Infant, Drug Withdrawal, Substance Abuse