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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2024
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
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 1 Hour 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Pittsburgh School of Medicine Pittsburgh Pennsylvania

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

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. — View 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: — View Citation

Liu VY, Flahive JM, Bloch-Salisbury E. Actigraphy: An Adjunctive Method to Measure Irritability in Opioid-Exposed Newborns. J Nurs Meas. 2023 Jun 23:JNM-2023-0020.R1. doi: 10.1891/JNM-2023-0020. Online ahead of print. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Respiratory Rate Respiratory rate at 1 week of age assessed for about 12 consecutive hours in a subset of subjects Assess respiratory rate for about 12 consecutive hours at week 1 of infant hospitalization
Primary 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).
Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days
Primary Cumulative Pharmacological Treatment- Morphine Dose Normalized cumulative morphine dose for infants who completed treatment at respective hospital site (mg/kg). Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Primary 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
Day of life infants discharged home, which is an expected mean of 21 days.
Primary 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
Day of life untreated infants discharged home, which is an expected mean of 21 days.
Primary 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
Day of life treated infants discharged home, which is an expected mean of 21 days.
Primary Length of Pharmacological Treatment-Duration For infants who received pharmacotherapy, total days of morphine treatment. Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Primary 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 Day of life infant started morphine treatment
Primary 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. Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Primary 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. 6 month and 12 months of life
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