Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

December 10, 2020 updated by: Elisabeth Salisbury, University of Massachusetts, Worcester
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).

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SVS vs Control
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.
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.
Absence of mattress Stochastic Vibratory Stimulation (SVS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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)
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)
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).
Single sessions throughout course of hospitalization. Each session may last up to 24 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Single session throughout course of hospitalization. Each session may last up to 24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elisabeth B Salisbury, Ph.D., University of Massachusetts, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2011

Primary Completion (Actual)

January 23, 2014

Study Completion (Actual)

December 15, 2019

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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