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Completed

NCT Number: NCT02768844

Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

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).

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Key information

Conditions

Neonatal Abstinence Syndrome Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Mental Disorders Substance Withdrawal Syndrome Substance-Related Disorders

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

About this study

Novel approaches to diagnosing and treating Neonatal Abstinence Syndrome (NAS) are needed for reducing prolonged pharmacological management, minimizing hospitalization and improving developmental outcomes in drug exposed newborns. This study seeks to examine the physiology and symptoms of drug withdrawal (e.g., irritability marked by movement activity; cardio-respiratory instabilities) in infants exposed to drugs in utero and test whether sensory stimuli (tactile, auditory) reduce dysregulated systems in the withdrawing infant.

Candidates at-risk for NAS due to fetal drug exposure will be identified to investigators by the infant's primary medical caregiver. Investigators will use a modified-consecutive sampling technique, restricted by equipment and personnel availability, for enrolling infants. Participants will be studied throughout their hospitalization. Effects of stimulation will be examined at different stages of withdrawal. Efficacy of stimulation will be examined as a potential complementary treatment of NAS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she:

  • 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

Treatment and study plan

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.

Control

Other

Absence of mattress Stochastic Vibratory Stimulation (SVS)

Primary outcomes

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

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

    Measure mean change in infant movement activity via limb sensors

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

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

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

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

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

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

Secondary outcomes

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

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

    Measure mean change in axillary temperature via temperature sensor.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2019
First posted
May 11, 2016
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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