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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
208
Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Number of Participants Administered Morphine Treatment
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).
Time frame: Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days
Cumulative Pharmacological Treatment- Morphine Dose
Normalized cumulative morphine dose for infants who completed treatment at respective hospital site (mg/kg).
Time frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Hospitalization Length of Stay
Day of life discharged home for untreated and treated infants who completed hospitalization at study site. Duration of infant hospitalization-Days
Time frame: Day of life infants discharged home, which is an expected mean of 21 days.
Hospitalization Length of Stay for Untreated Infants
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
Time frame: Day of life untreated infants discharged home, which is an expected mean of 21 days.
Hospitalization Length of Stay for Treated Infants
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
Time frame: Day of life treated infants discharged home, which is an expected mean of 21 days.
Length of Pharmacological Treatment-Duration
For infants who received pharmacotherapy, total days of morphine treatment.
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Time frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Trajectory of Symptom Severity Among Treated Infants
Days to start morphine treatment based on Finnegan severity scores among infants who met clinical criteria to treat
Time frame: Day of life infant started morphine treatment
Velocity of Weight Gain
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.
Time frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Neurobehavioral Outcomes Assessment
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.
Time frame: 6 month and 12 months of life