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Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns

NCT ID: NCT00516334

Last Updated: 2012-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2013-05-31

Brief Summary

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

Detailed Description

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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

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Brain Injury Seizures Cerebral Palsy

Keywords

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brain electroencephalography premature infant neurodevelopment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Linda J. Van Marter, M.D., M.P.H.

Attending Neonatologist and Associate Professor of Pediatrics Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Linda J Van Marter, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Deirdre O'Reilly, MD, MPH

Role: STUDY_DIRECTOR

Boston Children's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2003-P-000088

Identifier Type: -

Identifier Source: org_study_id