Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-02-03 @ 5:42 AM
Study NCT ID:
NCT00653692
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2008-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fetal Neurobehavior in Poly-drug Dependent Women
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Methadone, Buprenorphine and Fetal Neurobehavior
Status:
COMPLETED
Status Verified Date:
2013-02
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:
None
Brief Summary:
This project examines fetal neurobehavior and maternal physiology in poly-drug dependent women. This study also evaluates infant neonatal abstinence syndrome, infant neurobehavior and vagal tone in the post-partum period.
Detailed Description:
Little is known about the link between maternal physiology, fetal neurobehavior and neonatal abstinence syndrome in multiply drug-dependent women. Previous research by this group of investigators has found that the severity of neonatal abstinence syndrome in methadone exposed infants is related to maternal vagal tone changes in response to methadone during pregnancy. While previous research has focused on drug abstinent, methadone maintained women, most drug dependent pregnant women are poly-substance abusers who also use prescription psychiatric medications, alcohol and nicotine. This protocol seeks to further our understanding of the effects of multiple drugs on the fetus, including the co-variate effects of maternal psychological status. Infant neurobehavior and vagal tone will also be evaluated. This research will extend our knowledge of fetal neurobehavioral development and neonatal abstinence syndrome in a realistic population of poly-drug dependent women, potentially altering the way in which these women are evaluated and their infants monitored and treated for neonatal abstinence syndrome.
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 |
| DPMCDA | None | None | View |