Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns (BrainZ)
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ClinicalTrials.gov Identifier: NCT00516334
Verified July 2012 by Linda J. Van Marter, M.D., M.P.H., Brigham and Women's Hospital. Recruitment status was: Active, not recruiting
: August 15, 2007
Last Update Posted
: July 27, 2012
Brigham and Women's Hospital
Information provided by (Responsible Party):
Linda J. Van Marter, M.D., M.P.H., Brigham and Women's Hospital
This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.
Condition or disease
Brain InjurySeizuresCerebral Palsy
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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Ages Eligible for Study:
up to 36 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Infants <29 weeks gestational age
Infants inborn below 28 weeks gestation
At birth, deemed not likely to survive 7 days or more