Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns
This trial is active, not recruiting.
|Conditions||brain injury, seizures, cerebral palsy|
|Sponsor||Brigham and Women's Hospital|
|Start date||May 2006|
|End date||May 2009|
|Trial size||100 participants|
|Trial identifier||NCT00516334, 2003-P-000088|
This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.
Male or female participants up to 36 months old.
Inclusion Criteria: - Infants inborn below 28 weeks gestation Exclusion Criteria: - At birth, deemed not likely to survive 7 days or more - Major intracranial congenital anomaly
|Official title||Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury|
|Principal investigator||Linda J Van Marter, MD, MPH|
|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.|
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