Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

Not Applicable

Completed

• Conditions: Neonatal Abstinence Syndrome

• Registration Number: NCT02768844
• Lead Sponsor: University of Massachusetts, Worcester

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2014-01-23
• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-11
• Study Completion: 2019-12-15
• Status Verified: 2020-12
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Infant Movement between Mattress ON and Mattress OFF (control)	Single sessions throughout course of hospitalization. Each session may last up to 24 hours.	Measure mean change in infant movement activity via limb sensors
Change in Infant Breathing between Mattress ON and Mattress OFF (control)	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)
Change in Infant Heart Rate between Mattress ON and Mattress OFF(control)	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 Outcome Measures

Name	Time	Method
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.	Measure mean change in axillary temperature via temperature sensor.

Trial Locations

Locations (1)

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States