Gender Role Disorder, Male to Female Type Clinical Trial
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
| Verified date | March 2012 |
| Source | Medical University of Vienna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Ethikkommission |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 148 |
| Est. completion date | October 2011 |
| Est. primary completion date | December 2002 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 24 Weeks to 30 Weeks |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,