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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Linda J. Van Marter, M.D., M.P.H., Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00516334
First received: August 13, 2007
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition
Brain Injury
Seizures
Cerebral Palsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Estimated Enrollment: 100
Study Start Date: May 2006
Estimated Study Completion Date: May 2013
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Infants <29 weeks gestational age

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516334

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Linda J Van Marter, MD, MPH Brigham and Women's Hospital
Study Director: Deirdre O'Reilly, MD, MPH Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Linda J. Van Marter, M.D., M.P.H., Attending Neonatologist and Associate Professor of Pediatrics Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00516334     History of Changes
Other Study ID Numbers: 2003-P-000088
Study First Received: August 13, 2007
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
brain
electroencephalography
premature infant
neurodevelopment

Additional relevant MeSH terms:
Cerebral Palsy
Seizures
Brain Injuries
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Epilepsy
Neurologic Manifestations
Signs and Symptoms
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013