Status:
RECRUITING
Predictive Value of Neurovascular Coupling in Infants With COngenital Heart Disease
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Congenital Heart Disease
Neurodevelopmental Disorders
Eligibility:
All Genders
Up to 6 years
Brief Summary
Infants with congenital heart disease (CHD) are at increased risk for delayed neurodevelopment. Multiple etiological explanations have been proposed, as there seems to be a multifactorial interplay of...
Eligibility Criteria
Inclusion
- CHD warranting a first percutaneous or surgical intervention in the first 6 months, including but not limited to transposition of the great arteries (TGA), univentricular heart (UVH), Tetralogy of Fallot (TOF), coarctation of the aorta (CoA), total abnormal pulmonary venous drainage (TAPVU), Common arterial trunc (TA), large patent ductus arteriosus (PDA) or VSD and AVSD for which treatment is necessary within the first 6 months of life.
- Treatment provided at the University Hospitals Leuven.
Exclusion
- Syndromes or proven genetic conditions which are associated with neurological impairment
- CHD warranting treatment after 6 months of life
- Suspected or proven metabolic diseases
- No parental/guardian consent
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06190210
Start Date
December 1 2023
End Date
September 30 2027
Last Update
April 2 2025
Active Locations (1)
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1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000