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Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

Primary Purpose

Neonatal Abstinence Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stochastic Vibrotactile Stimulation (SVS)

Control

About this trial

This is an interventional treatment trial for Neonatal Abstinence Syndrome focused on measuring Stochastic Resonance, Fetus/Newborn Infant, Drug Withdrawal, Substance Abuse

Eligibility Criteria

1 Day - 1 Year (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Massachusetts Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SVS vs Control

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Measure mean change in infant movement activity via limb sensors

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

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

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

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

Secondary Outcome Measures

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

Measure mean change in axillary temperature via temperature sensor.

Full Information

NCT ID

NCT02768844

First Posted

May 2, 2016

Last Updated

December 10, 2020

Sponsor

University of Massachusetts, Worcester

1. Study Identification

Unique Protocol Identification Number

NCT02768844

Brief Title

Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

Official Title

Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

April 2011 (Actual)

Primary Completion Date

January 23, 2014 (Actual)

Study Completion Date

December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Massachusetts, Worcester

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neonatal Abstinence Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SVS vs Control

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Stochastic Vibrotactile Stimulation (SVS)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

Absence of mattress Stochastic Vibratory Stimulation (SVS)

Primary Outcome Measure Information:

Title

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

Description

Measure mean change in infant movement activity via limb sensors

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Measure mean change in axillary temperature via temperature sensor.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elisabeth B Salisbury, Ph.D.

Organizational Affiliation

University of Massachusetts, Worcester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Massachusetts Medical School

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35636580

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.

Results Reference

derived

PubMed Identifier

33348423

Citation

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.

Results Reference

derived

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Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

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