Gender-specific aEEGs and Outcome in Preterms

March 22, 2012 updated by: Monika Olischar, Medical University of Vienna

Gender-related Differences in Early Amplitude-integrated Electroencephalography in Newborns < 30 Weeks' Gestational Age and Their Correlation With Neurodevelopment Outcome at Three Years Corrected Age

Background and objectives: Male sex is a risk factor for poor neurodevelopmental outcome following preterm birth. The investigators aimed to investigate gender-related differences in amplitude-integrated electroencephalography (aEEG) and to correlate these findings with neurodevelopmental outcome.

Methods: Preterm infants born <30 weeks' gestational age between 2000 and 2002 were prospectively included. aEEGs obtained within the first two weeks of life were evaluated and classified according to background activity, sleep-wake cycling (SWC) and seizure activity. Outcome was assessed at three years.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

148

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

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

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

5 months to 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

preterms born < 30 weeks gestational age who had aEEG measurements within the first 2 weeks of life who had assessment of outcome at 3 years corrected age

Description

Inclusion Criteria:

  • born<30 weeks gestational age
  • who had aEEGs in first 2 weeks of life
  • who were assessed for outcome at 3 years of age

Exclusion Criteria:

  • born>30 weeks gestational age
  • had no aEEGs in first 2 weeks of life
  • lost for follow-up at 3 years

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

Medical University of Vienna

Investigators

  • Principal Investigator: Monika Olischar, MD, Neonatology

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

January 1, 2000

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (Estimate)

March 23, 2012

Study Record Updates

Last Update Posted (Estimate)

March 23, 2012

Last Update Submitted That Met QC Criteria

March 22, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • gender148

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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