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

Not Applicable

Completed

Conditions: Neonatal Abstinence Syndrome

Interventions: Device: Stochastic Vibrotactile Stimulation (SVS)

Registration Number: NCT02801331

Lead Sponsor: Elisabeth B Salisbury

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 208

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stochastic Vibrotactile Stimulation (SVS)	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).

Primary Outcome Measures

Name	Time	Method
Number of Participants Administered Morphine Treatment	Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days	Number of infants treated with morphine (first line pharmacotherapy at both sites). Number of infants who received pharmacotherapy (met clinical criteria to treat), index of NAS severity (per Finnegan scores).
Cumulative Pharmacological Treatment- Morphine Dose	Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days	Normalized cumulative morphine dose for infants who completed treatment at respective hospital site (mg/kg).
Hospitalization Length of Stay for Untreated Infants	Day of life untreated infants discharged home, which is an expected mean of 21 days.	Day of life discharged home for untreated infants (infants whose Finnegan scores did not meet criteria to treat) who completed hospitalization at study site. Duration of infant hospitalization-Days
Velocity of Weight Gain	Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days	Weight loss precedes weight gain in newborns. Days to weight nadir, defined as the lowest weight following birthweight. Velocity of weight gain was measured as days to return to birthweight, i.e., the day on which weight reached or surpassed birthweight following initial weight loss from birth.
Hospitalization Length of Stay	Day of life infants discharged home, which is an expected mean of 21 days.	Day of life discharged home for untreated and treated infants who completed hospitalization at study site. Duration of infant hospitalization-Days
Neurobehavioral Outcomes Assessment	6 month and 12 months of life	Scores for Cognitive Domain Bayley Scales of Infant and Toddler Development Third Edition. The standardized scores have a mean of 100 and standard deviation (SD) of 15. Scores below 1 SD (= or less than 84) is considered below normal. Scores above 1 SD (\>115) represent higher than normal functioning.
Hospitalization Length of Stay for Treated Infants	Day of life treated infants discharged home, which is an expected mean of 21 days.	Day of life discharged home for treated infants (infants whose Finnegan scores met criteria to treat) who completed hospitalization at study site. Duration of infant hospitalization-Days
Length of Pharmacological Treatment-Duration	Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days	For infants who received pharmacotherapy, total days of morphine treatment.
Trajectory of Symptom Severity Among Treated Infants	Day of life infant started morphine treatment	Days to start morphine treatment based on Finnegan severity scores among infants who met clinical criteria to treat