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Vagal Tone and Neonatal Abstinence Syndrome

Vagal Tone and Neonatal Abstinence Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00496951
Acronym
NAS
Enrollment
65
Registered
2007-07-06
Start date
2006-09-30
Completion date
2008-09-30
Last updated
2017-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Abstinence Syndrome, Vagal Tone

Keywords

Neonatal abstinence syndrome, Methadone, Vagal tone

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.

Interventions

DEVICEVagal 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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Days
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026