Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns (BrainZ)
Recruitment status was Active, not recruiting
This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury|
|Study Start Date:||May 2006|
|Estimated Study Completion Date:||May 2013|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516334
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Linda J Van Marter, MD, MPH||Brigham and Women's Hospital|
|Study Director:||Deirdre O'Reilly, MD, MPH||Children's Hospital Boston|