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Brain Function in Children With Congenital Heart Disease (CHD)

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ClinicalTrials.gov Identifier: NCT02814539
Recruitment Status : Enrolling by invitation
First Posted : June 27, 2016
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Bea Latal, University Children's Hospital, Zurich

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.

Condition or disease
Congenital Heart Disease

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Network Function in School-age Children With Congenital Heart Disease and Its Relation to Higher Order Cognitive Functions
Study Start Date : March 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

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



Primary Outcome Measures :
  1. Executive Functions, assessed with D-KEFS [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. slow wave activity on EEG [ Time Frame: 2 years ]
  2. MRI volumetry [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Primary care clinic
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814539


Sponsors and Collaborators
Bea Latal
University of Zurich
Investigators
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Principal Investigator: Bea Latal, MD MPH University Childrens Hospital Zurich

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Responsible Party: Bea Latal, Prof Dr med Bea Latal, University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT02814539     History of Changes
Other Study ID Numbers: BF_CHD_1
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities