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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease

• Study Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary care clinic

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
healthy controls
congenital heart disease; children with severe congenital heart disease who undergo open heart surgery during infancy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
slow wave activity on EEG	2 years
MRI volumetry	2 years

Collaborators and Investigators

• Sponsor: Bea Latal
• Collaborators: University of Zurich
• Investigators: Principal Investigator: Bea Latal, MD MPH, University Childrens Hospital Zurich

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (Estimate): June 27, 2016

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: BF_CHD_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No