Vagal Tone and Neonatal Abstinence Syndrome (NAS)
August 15, 2017 updated by: Johns Hopkins University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
65
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins Bayview Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 day (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Drug exposed infants
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (ACTUAL)
September 1, 2008
Study Completion (ACTUAL)
September 1, 2008
Study Registration Dates
First Submitted
July 5, 2007
First Submitted That Met QC Criteria
July 5, 2007
First Posted (ESTIMATE)
July 6, 2007
Study Record Updates
Last Update Posted (ACTUAL)
August 18, 2017
Last Update Submitted That Met QC Criteria
August 15, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6468
- R01DA019934 (U.S. NIH Grant/Contract)
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