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Gender-specific aEEGs and Outcome in Preterms

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01562236
First Posted: March 23, 2012
Last Update Posted: March 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Monika Olischar, Medical University of Vienna
  Purpose

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.


Condition
Gender Role Disorder, Male to Female Type

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Monika Olischar, Medical University of Vienna:

Enrollment: 148
Study Start Date: January 2000
Study Completion Date: October 2011
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Weeks to 30 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562236


Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Monika Olischar, MD Neonatology
  More Information

Responsible Party: Monika Olischar, Ass Prof Dr, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01562236     History of Changes
Other Study ID Numbers: gender148
First Submitted: March 22, 2012
First Posted: March 23, 2012
Last Update Posted: March 26, 2012
Last Verified: March 2012