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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Linda J. Van Marter, M.D., M.P.H., Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00516334
First Posted: August 15, 2007
Last Update Posted: July 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Linda J. Van Marter, M.D., M.P.H., Brigham and Women's Hospital
  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:


Further study details as provided by Linda J. Van Marter, M.D., M.P.H., 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Boston Children’s Hospital
  More Information

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
First Submitted: August 13, 2007
First Posted: August 15, 2007
Last Update Posted: July 27, 2012
Last Verified: July 2012

Keywords provided by Linda J. Van Marter, M.D., M.P.H., Brigham and Women's Hospital:
brain
electroencephalography
premature infant
neurodevelopment

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