Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns

• Conditions: Brain Injury; Seizures; Cerebral Palsy

• Registration Number: NCT00516334
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-08-13
• Study First Submitted QC: 2007-08-13
• Study First Posted: 2007-08-15
• Primary Completion: 2009-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-26
• Last Update Posted: 2012-07-27
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States