Gender-specific aEEGs and Outcome in Preterms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Monika Olischar, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01562236
First received: March 22, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  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 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

Ages Eligible for Study:   24 Weeks to 30 Weeks
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Monika Olischar, Ass Prof Dr, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01562236     History of Changes
Other Study ID Numbers: gender148
Study First Received: March 22, 2012
Last Updated: March 22, 2012
Health Authority: Austria: Ethikkommission

ClinicalTrials.gov processed this record on October 20, 2014