Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 9:34 AM
Study NCT ID:
NCT00516334
Status:
UNKNOWN
Last Update Posted:
2012-07-27
First Post:
2007-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury
Status:
UNKNOWN
Status Verified Date:
2012-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
BrainZ
Brief Summary:
This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.
Detailed Description:
Patient enrollment and electroencephalographic (EEG) and clinical data collection stopped May 2009. Data analysis is ongoing, and results have been described (O'Reilly D, Navakatikyan MA, Filip M, Greene D, Van Marter LJ. Peak to Peak Amplitude in Neonatal Brain Monitoring of Premature Infants. Clin Neurophysiol 2012 May 16), via publication in a peer-reviewed journal. Another manuscript has been completed and is undergoing revision for resubmission. We anticipate several additional articles will be completed from the data collected during this study. There is no relationship between industry and no current funding for this study. We maintain institutional review board approval due to ongoing data analysis.
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?: