Vagal Tone and Neonatal Abstinence Syndrome

Neonatal Abstinence Syndrome Clinical Trial

— NAS  

Official title:

Vagal Tone and Neonatal Abstinence Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496951
• Other study ID #: 6468
• Secondary ID: R01DA019934
• Status: Completed
• Phase: N/A
• First received: July 5, 2007
• Last updated: August 15, 2017
• Start date: September 2006
• Est. completion date: September 2008

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Syndrome
• Vagal Tone

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation