Brain Function in Children With Congenital Heart Disease (CHD)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02814539

Enrollment

Registered

2016-06-27

Start date

2016-03-31

Completion date

2019-09-30

Last updated

2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Years to 14 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Executive Functions, assessed with D-KEFS	2 years

Secondary

Measure	Time frame
slow wave activity on EEG	2 years
MRI volumetry	2 years

Outcome results