Brain Function in Children With Congenital Heart Disease (CHD)

NCT ID: NCT02814539

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-09-30

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.

Conditions

Congenital Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

congenital heart disease

children with severe congenital heart disease who undergo open heart surgery during infancy

No interventions assigned to this group

healthy controls

No interventions assigned to this group

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Zurich

OTHER

Sponsor Role: collaborator

Bea Latal

OTHER

Sponsor Role: lead

Responsible Party

Bea Latal

Prof Dr med Bea Latal

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bea Latal, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University Childrens Hospital Zurich

Other Identifiers

BF_CHD_1

Identifier Type: -

Identifier Source: org_study_id