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Completed

NCT Number: NCT02814539

Brain Function in Children With Congenital Heart Disease (CHD)

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Executive Functions, assessed with D-KEFS

    Time frame: 2 years

Secondary outcomes

  1. slow wave activity on EEG

    Time frame: 2 years

  2. MRI volumetry

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Bea Latal

Other

Collaborators

  • University of Zurich

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2016
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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