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

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. Identifier: NCT00516334
Recruitment Status : Unknown
Verified July 2012 by Linda J. Van Marter, M.D., M.P.H., Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 15, 2007
Last Update Posted : July 27, 2012
Information provided by (Responsible Party):
Linda J. Van Marter, M.D., M.P.H., Brigham and Women's Hospital

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

Condition or disease
Brain Injury Seizures Cerebral Palsy

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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury
Study Start Date : May 2006
Actual Primary Completion Date : May 2009
Estimated Study Completion Date : May 2013

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00516334

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

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 Identifier: NCT00516334     History of Changes
Other Study ID Numbers: 2003-P-000088
First Posted: August 15, 2007    Key Record Dates
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:
premature infant

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