Vagal Tone and Neonatal Abstinence Syndrome - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00496951

Purpose

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.

Condition	Intervention
Neonatal Abstinence Syndrome Vagal Tone	Device: Vagal tone assessment

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Vagal Tone and Neonatal Abstinence Syndrome

Further study details as provided by National Institute on Drug Abuse (NIDA):

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	65
Study Start Date:	September 2006
Study Completion Date:	September 2008

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	up to 1 Day
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Drug exposed infants

Criteria

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 NICU
Psychiatric impairment of the mother such that informed consent is not possible

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496951

Locations

United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Lauren M Jansson, MD

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Johns Hopkins University School of Medicine ( Lauren Jansson / Assistant Prfessor of Pediatrics )
Study ID Numbers:	6468, NIDA R01DA019934, DPMCDA
Study First Received:	July 5, 2007
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00496951 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Neonatal abstinence syndrome
Methadone
Vagal tone

Study placed in the following topic categories:

Methadone
Mental Disorders
Neonatal Abstinence Syndrome

Substance-Related Disorders
Disorders of Environmental Origin
Infant, Newborn, Diseases

Additional relevant MeSH terms:

Pathologic Processes
Disease
Mental Disorders
Neonatal Abstinence Syndrome

Syndrome
Substance-Related Disorders
Disorders of Environmental Origin
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 07, 2009