- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01615523
Executive Function in Preterm Born Children: An Integrative Approach From Genetics to Brain Function
June 7, 2012 updated by: University of Zurich
Hd-EEG and MRI measures are used to study the maturation of functional networks in order to identify the neural circuits underlying executive and memory processes in children born preterm.
It will be determined whether children born preterm with executive function deficits will have an abnormal connectivity between basal ganglia and cortex due to WM injury.
Moreover, the development of hd-EEG activity during sleep (coherence and travelling waves) and brain maturation of children and adolescents born preterm will be compared with the respective measures in healthy controls.
This is of eminent importance as it helps to understand the nature of executive function and hence, it may help to develop neuroprotective strategies to prevent executive function deficits in these infants.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cornelia Franziska Hagmann, MD
- Email: cornelia.hagmann@usz.ch
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Division of Neonatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 16 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children and adolescents born preterm with their peers as controls
Description
Inclusion criteria:
- Schoolchildren between 10 and 12 or 14 and 16 (born between 1996 and 1998 or between 2000 and 2002)
- Preterm group: born <32 weeks of gestation
- Control group: siblings or friends of preterm group in one of the two age groups
Exclusion criteria:
- Preterm Group: MDI < 85 at 5 years of age; cerebral palsy
- Control Group: born <37 weeks of gestation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children/adolescents born preterm
|
Sleep EEG and one MRI, executive function testing using Strrop test, BRIEF questionnaire and CantabEclipse
|
Control children and adolescents
|
Sleep EEG and one MRI, executive function testing using Strrop test, BRIEF questionnaire and CantabEclipse
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cornelia F Hagmann, MD, University Hospital Zurich, Division of Neonatology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (ANTICIPATED)
December 1, 2015
Study Completion (ANTICIPATED)
December 1, 2015
Study Registration Dates
First Submitted
June 6, 2012
First Submitted That Met QC Criteria
June 7, 2012
First Posted (ESTIMATE)
June 8, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
June 8, 2012
Last Update Submitted That Met QC Criteria
June 7, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EF_MRI_EEG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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