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NCT00496951 · ClinicalTrials.gov registry record
Vagal Tone and Neonatal Abstinence Syndrome
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 65
- Enrollment target
NCT00496951: Completed study, sponsored by Johns Hopkins University.
NCT00496951 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 65 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00496951 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 65 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Vagal tone assessment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2006-09 |
| Est. Completion | 2008-09 |
What the finished NCT00496951 record still lists
NCT00496951 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 65 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Vagal tone assessment is the first listed.
NCT00496951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00496951 about?
NCT00496951 is a clinical study titled "Vagal Tone and Neonatal Abstinence Syndrome". 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 pathophysiol...
What is the current status of trial NCT00496951?
This trial is currently completed. The enrollment target is 65 participants. The study started on 2006-09. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00496951?
The interventions under investigation include: Vagal tone assessment (DEVICE).
Who is sponsoring clinical trial NCT00496951?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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