Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-02 @ 11:59 AM
Study NCT ID:
NCT00496951
Status:
COMPLETED
Last Update Posted:
2017-08-18
First Post:
2007-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vagal Tone and Neonatal Abstinence Syndrome
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Vagal Tone and Neonatal Abstinence Syndrome
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAS
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DA019934 | NIH | None | https://reporter.nih.gov/quic… | View |