Vagal Tone and Neonatal Abstinence Syndrome

NCT ID: NCT00496951

Last Updated: 2017-08-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-09-30

Brief Summary

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.

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.

Conditions

Neonatal Abstinence Syndrome; Vagal Tone

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

EKG monitor (R wave electronics); Vagal tone monitor (Delta Biometrix)

Eligibility 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

• Maximum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren M Jansson, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

References

Jansson LM, Dipietro JA, Elko A, Velez M. Infant autonomic functioning and neonatal abstinence syndrome. Drug Alcohol Depend. 2010 Jun 1;109(1-3):198-204. doi: 10.1016/j.drugalcdep.2010.01.004. Epub 2010 Mar 1.

Reference Type: RESULT

PMID: 20189732 (View on PubMed)

Other Identifiers

R01DA019934

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6468

Identifier Type: -

Identifier Source: org_study_id