Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns - Full Text View

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

This study is currently recruiting participants.

Verified May 2010 by Brigham and Women's Hospital

First Received on August 13, 2007. Last Updated on May 3, 2010 History of Changes

Sponsor:	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

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:

MedlinePlus related topics: Cerebral Palsy Paralysis Seizures Traumatic Brain Injury

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 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Eligibility

Study Population

Infants <29 weeks gestational age

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

No publications provided

Responsible Party:	Linda J Van Marter, MD, MPH, 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:	May 3, 2010
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 February 09, 2012