Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Injury
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 100
- Locations
- 1
- Last Updated
- 13 years ago
Overview
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.
Investigators
Linda J. Van Marter, M.D., M.P.H.
Attending Neonatologist and Associate Professor of Pediatrics Harvard Medical School
Brigham and Women's Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified