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NCT02814539 Clinical Trial

Brain Function in Children With Congenital Heart Disease (CHD)

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02814539
Other study ID # BF_CHD_1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2016
Est. completion date September 2019

Study information
Verified date September 2019
Source University Children's Hospital, Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 14 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Bea Latal University of Zurich

Outcome
Type Measure Description Time frame Safety issue
Primary Executive Functions, assessed with D-KEFS 2 years
Secondary slow wave activity on EEG 2 years
Secondary MRI volumetry 2 years
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