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NCT01615523 Clinical Trial

Executive Function in Preterm Born Children: An Integrative Approach From Genetics to Brain Function

Preterm Infants Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01615523
Other study ID # EF_MRI_EEG
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 6, 2012
Last updated June 7, 2012
Start date September 2012
Est. completion date December 2015

Study information
Verified date June 2012
Source University of Zurich
Contact Cornelia Franziska Hagmann, MD
Email cornelia.hagmann@usz.ch
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 10 Years to 16 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• MRI, EEG and cognitive testing
Sleep EEG and one MRI, executive function testing using Strrop test, BRIEF questionnaire and CantabEclipse

Locations
Country Name City State
Switzerland University Hospital Zurich, Division of Neonatology Zurich ZH

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

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