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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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

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