NCT00516334

Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns

Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 36 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Injury
• Seizures
• Cerebral Palsy

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-05-01
• Completion: 2013-05-01
• First posted: 2007-08-15
• Last updated: 2012-07-27

Locations

1 site across 1 country: United States