Vagal Tone and Neonatal Abstinence Syndrome
Completed
Conditions studied: Neonatal Abstinence Syndrome, Vagal Tone
In brief
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.
Key facts
- Study ID
- NCT00496951
- Run by
- Johns Hopkins University
- People needed
- 65
- Starts
- 2006-09-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2017-08-18
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.