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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Zurich.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01615523
First received: June 6, 2012
Last updated: June 7, 2012
Last verified: June 2012
  Purpose
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.

Condition Intervention
Preterm Infants
Other: MRI, EEG and cognitive testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by University of Zurich:

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Children/adolescents born preterm Other: MRI, EEG and cognitive testing
Sleep EEG and one MRI, executive function testing using Strrop test, BRIEF questionnaire and CantabEclipse
Control children and adolescents Other: MRI, EEG and cognitive testing
Sleep EEG and one MRI, executive function testing using Strrop test, BRIEF questionnaire and CantabEclipse

  Eligibility

Ages Eligible for Study:   10 Years to 16 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescents born preterm with their peers as controls
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615523

Contacts
Contact: Cornelia Franziska Hagmann, MD cornelia.hagmann@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Neonatology Not yet recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Cornelia F Hagmann, MD University Hospital Zurich, Division of Neonatology
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01615523     History of Changes
Other Study ID Numbers: EF_MRI_EEG 
Study First Received: June 6, 2012
Last Updated: June 7, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Executive functions

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 28, 2016