Gender Role Disorder, Male to Female TypeNCT01562236
Gender-specific aEEGs and Outcome in Preterms
An observational study of Gender Role Disorder, Male to Female Type, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 to 30 weeksHealthy volunteers can take part
- Conditions the study is for
- Gender Role Disorder, Male to Female Type
- How many people
- 148 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2000to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 30 weeks
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- born<30 weeks gestational age
- who had aEEGs in first 2 weeks of life
- who were assessed for outcome at 3 years of age
Who cannot join
- born>30 weeks gestational age
- had no aEEGs in first 2 weeks of life
- lost for follow-up at 3 years
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startJan 2000
- Primary completionDec 2002
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender Role Disorder, Male to Female TypeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monika Olischar, Medical University of Vienna
- Investigators
- Monika Olischar, MD, Principal investigator, Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562236
- Sponsor's protocol ID
- gender148
- Status last verified
- Mar 2012
- First submitted
- 22 Mar 2012
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01562236
- Acronym / sponsor ID
- gender148
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2002 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 24 to 30 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- born<30 weeks gestational age
- who had aEEGs in first 2 weeks of life
- who were assessed for outcome at 3 years of age
Key exclusion criteria (3 listed)
- born>30 weeks gestational age
- had no aEEGs in first 2 weeks of life
- lost for follow-up at 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Olischar, MD principal investigator
Neonatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Role Disorder, Male to Female Type, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2012.