Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns

Brigham and Women's Hospital100 enrolled

Overview

This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Brain Injury Seizures Cerebral Palsy

Eligibility

Sex: ALLMin age: 1 DayMax age: 36 Months

Medical Language ↔ Plain English

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

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Data from ClinicalTrials.gov

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