- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01562236
Gender-specific aEEGs and Outcome in Preterms
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
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- Medical University of Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Monika Olischar, MD, Neonatology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- gender148
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