Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

NCT02768844 | Completed FDA Device

• 1 other identifier: H00006578
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of this project is to to quantify the physiology of neonatal drug withdrawal and develop non-pharmacological techniques to help improve the therapeutic management of Neonatal Abstinence Syndrome (NAS).

Conditions

Neonatal Abstinence Syndrome

Keywords

Stochastic Resonance; Fetus/Newborn Infant; Drug Withdrawal; Substance Abuse

Outcome Measures

Primary Outcomes (3)

• Change in Infant Movement between Mattress ON and Mattress OFF (control)

  Measure mean change in infant movement activity via limb sensors

  Single sessions throughout course of hospitalization. Each session may last up to 24 hours.

• Change in Infant Breathing between Mattress ON and Mattress OFF (control)

  Measure mean change in infant respiratory rate via respiratory inductance plethysmography (RIP)

  Single sessions throughout course of hospitalization. Each session may last up to 24 hours.

• Change in Infant Heart Rate between Mattress ON and Mattress OFF(control)

  Measure mean change in infant heart rate via Electrocardiography (ECG).

  Single sessions throughout course of hospitalization. Each session may last up to 24 hours.

Secondary Outcomes (1)

• Change in Infant Temperature between Mattress ON and Mattress OFF (control)

  Single session throughout course of hospitalization. Each session may last up to 24 hours.

Study Arms (1)

SVS vs Control

EXPERIMENTAL

Prospective, within-subject design. Compare effects of mattress SVS (ON) and Control (SVS OFF) on physiology in opioid-exposed newborns. SVS is alternated in intervals between continuous stimulation (ON) and no stimulation (OFF/Control) throughout inter-feed intervals. The order of the ON-OFF cycles is randomized across subjects and counterbalanced between feeding periods within subjects.

Device: Stochastic Vibrotactile Stimulation (SVS); Other: Control

Interventions

Stochastic Vibrotactile Stimulation (SVS) DEVICE

The infant's isolette mattress will be replaced with a specially designed mattress (non-commercially available; designed by Wyss Institute, Harvard University, Cofab Design LLC) to provide gentle vibrations and sounds during mattress stimulations.

SVS vs Control

Control OTHER

Absence of mattress Stochastic Vibratory Stimulation (SVS)

SVS vs Control

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Eligible subjects are infants currently inpatient in the NICU or Newborn Nursery at University of Massachusetts Memorial Hospital and:
• Full-term infants (\>37 wks gestational age) and late preterm infants (34-37 wks gestational age)
• Newborns at risk for NAS due to fetal-drug exposure
• At-risk infants will be infants who present with confirmed meconium and/or urine toxicology report (documented in medical chart review) for opioids (e.g., methadone, buprenorphine/subutex, oxycodone, heroin); may also have prenatal exposure to benzodiazepines, barbiturates, amphetamines, cannabinoids, alcohol, nicotine and/or caffeine.

You may not qualify if:

• Born less than \<34 weeks.
• Has a congenital abnormality
• Has a fetal anomaly
• Has hydrocephalus or intraventricular hemorrhage \>grade 2
• Has a seizure disorder not related to drug withdrawal
• Has a clinically significant shunt
• Requires mechanical respiratory support

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (2)

• 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.

  PMID: 35636580 DERIVED

• 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.

  PMID: 33348423 DERIVED

MeSH Terms

Conditions

Neonatal Abstinence Syndrome; Substance Withdrawal Syndrome; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Elisabeth B Salisbury, Ph.D.

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 11, 2016
• Study Start: April 1, 2011
• Primary Completion: January 23, 2014
• Study Completion: December 15, 2019
• Last Updated: March 20, 2025

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)