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Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns (BrainZ)

Mass General Brigham logo

Mass General Brigham

Status

Unknown

Conditions

Seizures
Brain Injury
Cerebral Palsy

Study type

Observational

Funder types

Other

Identifiers

NCT00516334
2003-P-000088

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

1 day to 36 months old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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