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

This study is currently recruiting participants.
Verified by Brigham and Women's Hospital, August 2007

Sponsored by: Brigham and Women's Hospital
Information provided by: Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00516334
  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

MedlinePlus related topics:   Cerebral Palsy    Head and Brain Injuries    Seizures   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Longitudinal, Defined Population, Prospective Study
Official Title:   Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury

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

Estimated Enrollment:   100
Study Start Date:   May 2006

  Eligibility
Ages Eligible for Study:   up to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

Contacts
Contact: Deirdre O'Reilly, MD, MPH     617-355-6027     deirdre.oreilly@childrens.harvard.edu    
Contact: Linda J Van Marter, MD, MPH     617-355-6027     linda.vanmarter@childrens.harvard.edu    

Locations
United States, Massachusetts
Brigham and Women's Hospital     Recruiting
      Boston, Massachusetts, United States, 02115
      Principal Investigator: Linda J Van Marter, MD, MPH            
      Sub-Investigator: Deirdre O'Reilly, MD, MPH            

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

Study ID Numbers:   2003-P-000088
First Received:   August 13, 2007
Last Updated:   August 13, 2007
ClinicalTrials.gov Identifier:   NCT00516334
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Craniocerebral Trauma
Paralysis
Cerebral Palsy
Brain Damage, Chronic
Seizures
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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