Overview

This trial is active, not recruiting.

Conditions brain injury, seizures, cerebral palsy
Sponsor Brigham and Women's Hospital
Start date May 2006
End date May 2009
Trial size 100 participants
Trial identifier NCT00516334, 2003-P-000088

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

Male or female participants up to 36 months old.

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

Additional Information

Official title Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury
Principal investigator Linda J Van Marter, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.