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

Neonatal Abstinence Syndrome Clinical Trial

Official title:

A Randomized Controlled Study of Stochastic Vibrotactile Stimulation for Neonatal Abstinence Syndrome: Therapeutic Efficacy and Neurobehavioral Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801331
• Other study ID #: STUDY21040054
• Secondary ID: 1R01DA042074-01
• Status: Completed
• Phase: N/A
• Start date: March 9, 2017
• Est. completion date: June 6, 2021

Study information

• Verified date: February 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: June 6, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Syndrome

Intervention

Device:
• Stochastic Vibrotactile Stimulation (SVS)
Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle vibrations and sounds during mattress stimulations.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Elisabeth Salisbury, PhD	National Institute on Drug Abuse (NIDA), University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Respiratory rate	Respiratory rate at 1 and/or 2 weeks of age assessed for about 12 consecutive hours in a subset of hospitalized subjects	Assess respiratory rate for about 12 consecutive hours at week 1 and week 2 of infant hospitalization
Other	Cardiac activity	Heart rate at 1 and/or 2 weeks of age assessed for about 12 consecutive hours in a subset of hospitalized subjects	Assess heart rate for about 12 consecutive hours at week 1 and week 2 of infant hospitalization
Primary	Pharmacological Treatment-Dose	Cumulative morphine dose	Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Primary	Pharmacological Treatment-Duration	Total days of morphine treatment	Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Primary	Neurobehavioral Outcomes Assessment	Neurobehavioral infant assessment at 6 month followup	Participants will be assessed at approx 1 month, 6 months, and 12 months
Secondary	Velocity of weight gain	Trajectory of weight gain throughout hospitalization-Days to return to birth weight	Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Secondary	Hospitalization length of stay	Duration of infant hospitalization	Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days