Clinical trial NCT02801331: Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome
Official title: A Randomized Controlled Study of Stochastic Vibrotactile Stimulation for Neonatal Abstinence Syndrome: Therapeutic Efficacy and Neurobehavioral Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Abstinence Syndrome
Keywords: Stochastic Resonance
Fetus/Newborn Infant
Drug Withdrawal
Substance Abuse
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: National Institute on Drug Abuse (NIDA)
name: University of Massachusetts, Worcester
First posted: 2016-06-15
Enrollment: 208
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Administered Morphine Treatment
timeFrame: Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days
measure: Cumulative Pharmacological Treatment- Morphine Dose
timeFrame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
measure: Hospitalization Length of Stay
timeFrame: Day of life infants discharged home, which is an expected mean of 21 days.
measure: Hospitalization Length of Stay for Untreated Infants
timeFrame: Day of life untreated infants discharged home, which is an expected mean of 21 days.
measure: Hospitalization Length of Stay for Treated Infants
timeFrame: Day of life treated infants discharged home, which is an expected mean of 21 days.
measure: Length of Pharmacological Treatment-Duration
timeFrame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
measure: Trajectory of Symptom Severity Among Treated Infants
timeFrame: Day of life infant started morphine treatment
measure: Velocity of Weight Gain
timeFrame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
measure: Neurobehavioral Outcomes Assessment
timeFrame: 6 month and 12 months of life
Secondary outcomes:
Other outcomes:
measure: Respiratory Rate
timeFrame: Assess respiratory rate for about 12 consecutive hours at week 1 of infant hospitalization
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Elisabeth B Salisbury, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bloch-Salisbury E, Bogen D, Vining M, Netherton D, Rodriguez N, Bruch T, Burns C, Erceg E, Glidden B, Ayturk D, Aurora S, Yanowitz T, Barton B, Beers S. Study design and rationale for a randomized controlled trial to assess effectiveness of stochastic vibrotactile mattress stimulation versus standard non-oscillating crib mattress for treating hospitalized opioid-exposed newborns. Contemp Clin Trials Commun. 2021 Feb 11;21:100737. doi: 10.1016/j.conctc.2021.100737. eCollection 2021 Mar.
citation: Bloch-Salisbury E, Rodriguez N, Bruch T, McKenna L, Goldschmidt L. Physiologic dysregulation in newborns with prenatal opioid exposure: Cardiac, respiratory and movement activity. Neurotoxicol Teratol. 2022 Jul-Aug;92:107105. doi: 10.1016/j.ntt.2022.107105. Epub 2022 May 27.
citation: Liu VY, Flahive JM, Bloch-Salisbury E. Actigraphy: An Adjunctive Method to Measure Irritability in Opioid-Exposed Newborns. J Nurs Meas. 2024 Oct 24;32(3):467-476. doi: 10.1891/JNM-2023-0020.
citation: Bloch-Salisbury E, Wilson JD, Rodriguez N, Bruch T, McKenna L, Derbin M, Glidden B, Ayturk D, Aurora S, Yanowitz T, Barton B, Vining M, Beers SR, Bogen DL. Efficacy of a Vibrating Crib Mattress to Reduce Pharmacologic Treatment in Opioid-Exposed Newborns: A Randomized Clinical Trial. JAMA Pediatr. 2023 Jul 1;177(7):665-674. doi: 10.1001/jamapediatrics.2023.1077.
citation: Pahl A, Young L, Buus-Frank ME, Marcellus L, Soll R. Non-pharmacological care for opioid withdrawal in newborns. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD013217. doi: 10.1002/14651858.CD013217.pub2.