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

July 26, 2012 updated by: Linda J. Van Marter, M.D., M.P.H., Brigham and Women's Hospital

Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury

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

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants <29 weeks gestational age

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

May 1, 2009

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

August 13, 2007

First Submitted That Met QC Criteria

August 13, 2007

First Posted (Estimate)

August 15, 2007

Study Record Updates

Last Update Posted (Estimate)

July 27, 2012

Last Update Submitted That Met QC Criteria

July 26, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-P-000088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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