Brain Function in Children With Congenital Heart Disease (CHD)

Completed

• Conditions: Congenital Heart Disease

• Registration Number: NCT02814539
• Lead Sponsor: Bea Latal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-27
• Status Verified: 2019-09
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Executive Functions, assessed with D-KEFS	2 years

Secondary Outcome Measures

Name	Time	Method
MRI volumetry	2 years
slow wave activity on EEG	2 years