A Randomized Controlled Study of Stochastic Vibrotactile Stimulation for Neonatal Abstinence Syndrome: Therapeutic Efficacy and Neurobehavioral Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Number of Participants Administered Morphine Treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Stochastic Vibrotactile Stimulation (SVS) (Device)
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.
结局指标
主要结局
Number of Participants Administered Morphine Treatment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Elisabeth B Salisbury
Visiting Associate Professor
University of Pittsburgh