Vagal Tone and Neonatal Abstinence Syndrome

Symptoms of Neonatal Abstinence Syndrome (NAS) can be attributed largely to dysfunction of the autonomic nervous system in opiate exposed neonates. Vagal tone is a readily available measure of autonomic nervous system functioning. NAS is a widely variable disorder with poorly understood pathophysiology; while all opiate exposed infants will exhibit some signs and symptoms of NAS, only approximately ½ have severe enough symptoms to require pharmacologic therapy. This research seeks to determine the relationship between infant vagal tone and NAS severity. The determination of a link between newborn vagal tone and NAS severity could result in the prediction of infants at risk for severe NAS and provide these infants and mothers with intensified services and early treatment, thereby shortening the course of NAS in the infant.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this study

Consecutively born methadone exposed infants had hert period and cardiac vagal tone measurements extracted via standard EKGs on days 1 and 3 of life. The infant's NAS course was assessed serially.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Term infant (>= 37 weeks by 1st or second trimester sonogram),
In utero opiate exposure (either heroin or methadone) requiring a minimum of three day infant hospitalization after birth
Delivery to a client active in drug abuse treatment

Exclusion criteria

Significant medical complications in the infant
Circumcision within 24 hours of the proposed EKG/vagal tone measurement (circumcision has been found to affect vagal tone)
Infant hospitalization in the Neonatal Intensive Care Unit (NICU)
Psychiatric impairment of the mother such that informed consent is not possible

Treatment and study plan

Vagal tone assessment

Device

An EKG will be obtained using a Physio-control EKG monitor (R wave Electronics of Florida) in standard application, with three chest leads. The EKG data is inputted into a vagal tone monitor (Delta Biometrix, Bethesda MD) which computes vagal tone from the EKG signal. This data is then transferred to a disk which is analyzed off-line.

Other names: EKG monitor (R wave electronics), Vagal tone monitor (Delta Biometrix)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

National Institute on Drug Abuse (NIDA)

Registry information

Acronym: NAS

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jul 6, 2007
Registry last updated: Aug 18, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed