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Clinical Trials/NCT02814539
NCT02814539
Completed
N/A

Brain Network Function in School-age Children With Congenital Heart Disease and Its Relation to Higher Order Cognitive Functions

Bea Latal0 sites50 target enrollmentMarch 2016
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ConditionsCongenital Heart Disease

Overview

Phase
N/A
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Bea Latal
Enrollment
50
Primary Endpoint
Executive Functions, assessed with D-KEFS
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

The purpose of the study is to determine whether the neurodevelopmental outcome and in particular executive functions in 9 to 14 year old school children with congenital heart disease who underwent cardiopulmonary bypass surgery during their first three months of life is impaired in comparison to healthy children at same age. Executive functions are higher order cognitive functions and critical for school success.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
September 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bea Latal
Responsible Party
Sponsor Investigator
Principal Investigator

Bea Latal

Prof Dr med Bea Latal

University Children's Hospital, Zurich

Eligibility Criteria

Inclusion Criteria

  • •Congenital heart disease,
  • •Cardiopulmonary bypass surgery during first three months of life,
  • •No genetic syndrome,
  • •Gestational age \> 37 weeks of gestation.

Exclusion Criteria

  • •Heart surgery without cardiopulmonary bypass,
  • •Heart surgery not within first three months of life,
  • •Born \<37 weeks of gestation,
  • •Any genetic syndrome detected.

Outcomes

Primary Outcomes

Executive Functions, assessed with D-KEFS

Time Frame: 2 years

Secondary Outcomes

  • slow wave activity on EEG(2 years)
  • MRI volumetry(2 years)

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