Vagal Tone and Neonatal Abstinence Syndrome (NAS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lauren M. Jansson, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00496951
First received: July 5, 2007
Last updated: February 20, 2013
Last verified: February 2013
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vagal Tone and Neonatal Abstinence Syndrome

Further study details as provided by Johns Hopkins University:

Enrollment: 65
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Vagal tone assessment
    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)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Johns Hopkins University
Investigators
Principal Investigator: Lauren M Jansson, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Lauren M. Jansson, Associate Professor of Pediatrics Johns Hopkins University School of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00496951     History of Changes
Other Study ID Numbers: 6468, R01DA019934, NIDA R01DA019934, DPMCDA
Study First Received: July 5, 2007
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Johns Hopkins University:
Neonatal abstinence syndrome
Methadone
Vagal tone

Additional relevant MeSH terms:
Syndrome
Neonatal Abstinence Syndrome
Disease
Pathologic Processes
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014