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: April 2024
• 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: 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

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, 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

External Links

•   Actigraphy: An Adjunctive Method to Measure Irritability in Opioid-Exposed Newborns
•   Efficacy of a Vibrating Crib Mattress to Reduce Pharmacologic Treatment in Opioid-Exposed Newborns: A Randomized Clinical Trial
•   Physiologic dysregulation in newborns with prenatal opioid exposure: Cardiac, respiratory and movement activity
•   Study design and rationale for a randomized controlled trial to assess effectiveness...