Gender-specific aEEGs and Outcome in Preterms

NCT ID: NCT01562236

Last Updated: 2012-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gender Role Disorder, Male to Female Type

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

30 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Monika Olischar

Ass Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Monika Olischar, MD

Role: PRINCIPAL_INVESTIGATOR

Neonatology

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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gender148

Identifier Type: -

Identifier Source: org_study_id

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