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

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ClinicalTrials.gov Identifier: NCT02801331
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : August 10, 2021
Sponsor:
Collaborators:
University of Pittsburgh
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Elisabeth Salisbury, PhD, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Neonatal Abstinence Syndrome Device: Stochastic Vibrotactile Stimulation (SVS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Stochastic Vibrotactile Stimulation for Neonatal Abstinence Syndrome: Therapeutic Efficacy and Neurobehavioral Outcomes
Actual Study Start Date : March 9, 2017
Actual Primary Completion Date : March 5, 2021
Actual Study Completion Date : June 6, 2021

Arm Intervention/treatment
Experimental: 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). Infants will be scored for severity of withdrawal using standardized, modified Finnegan scoring system by clinical care nurses per routine clinical care throughout hospitalization.
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.

No Intervention: 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. Infants will be scored for severity of withdrawal using standardized, modified Finnegan scoring system by clinical care nurses per routine clinical care throughout hospitalization.



Primary Outcome Measures :
  1. Pharmacological Treatment-Dose [ Time Frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days ]
    Cumulative morphine dose

  2. Pharmacological Treatment-Duration [ Time Frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days ]
    Total days of morphine treatment

  3. Neurobehavioral Outcomes Assessment [ Time Frame: Participants will be assessed at approx 1 month, 6 months, and 12 months ]
    Neurobehavioral infant assessment at 6 month followup


Secondary Outcome Measures :
  1. Velocity of weight gain [ Time Frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days ]
    Trajectory of weight gain throughout hospitalization-Days to return to birth weight

  2. Hospitalization length of stay [ Time Frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days ]
    Duration of infant hospitalization


Other Outcome Measures:
  1. Respiratory rate [ Time Frame: Assess respiratory rate for about 12 consecutive hours at week 1 and week 2 of infant hospitalization ]
    Respiratory rate at 1 and/or 2 weeks of age assessed for about 12 consecutive hours in a subset of hospitalized subjects

  2. Cardiac activity [ Time Frame: Assess heart rate for about 12 consecutive hours at week 1 and week 2 of infant hospitalization ]
    Heart rate at 1 and/or 2 weeks of age assessed for about 12 consecutive hours in a subset of hospitalized subjects



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Ages Eligible for Study:   up to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801331


Locations
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United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
Elisabeth Salisbury, PhD
University of Pittsburgh
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Elisabeth B Salisbury, Ph.D. University of Massachusetts, Worcester
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elisabeth Salisbury, PhD, Research Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02801331    
Other Study ID Numbers: STUDY21040054
1R01DA042074-01 ( U.S. NIH Grant/Contract )
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Elisabeth Salisbury, PhD, University of Pittsburgh:
Stochastic Resonance
Fetus/Newborn Infant
Drug Withdrawal
Substance Abuse
Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Syndrome
Disease
Pathologic Processes
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders