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Vagal Tone and Neonatal Abstinence Syndrome (NAS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00496951
First Posted: July 6, 2007
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
  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)
Detailed Description:
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.
  Eligibility

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
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 Neonatal Intensive Care Unit (NICU)
  • Psychiatric impairment of the mother such that informed consent is not possible
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496951


Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Lauren M Jansson, MD Johns Hopkins University
  More Information

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00496951     History of Changes
Other Study ID Numbers: 6468
R01DA019934 ( U.S. NIH Grant/Contract )
First Submitted: July 5, 2007
First Posted: July 6, 2007
Last Update Posted: August 18, 2017
Last Verified: August 2017

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