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

Status

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Completed

Conditions

Conditions

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Study Type

Study Type

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Observational

Enrollment (Actual)

Enrollment

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148

Contacts and Locations

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Study Locations

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

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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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

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How is the study designed?

Design Details

Collaborators and Investigators

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Vienna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Monika Olischar, MD, Neonatology

Study record dates

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Study Major Dates

Study Start

Study Start

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January 1, 2000

Primary Completion (Actual)

Primary Completion

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December 1, 2002

Study Completion (Actual)

Study Completion

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October 1, 2011

Study Registration Dates

First Submitted

First Submitted

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March 22, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

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March 22, 2012

First Posted (Estimate)

First Posted

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March 23, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • gender148

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