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

Elisabeth B Salisbury

Status: Completed

Conditions: Neonatal Abstinence Syndrome

Treatments: Device: Stochastic Vibrotactile Stimulation (SVS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02801331

1R01DA042074-01 (U.S. NIH Grant/Contract)

STUDY21040054

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 208 patients

Sex: All

Ages: 1 hour to 18 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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208 participants in 2 patient groups

Stochastic Vibrotactile Stimulation (SVS)

Experimental group

Description:

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).

Treatment:

Device: Stochastic Vibrotactile Stimulation (SVS)

Treatment as Usual (TAU)

No Intervention group

Description:

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.