Predictive Value of Neurovascular Coupling in Infants With COngenital Heart Disease
Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jan 2, 2024
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how certain factors related to heart surgery in infants with congenital heart disease (CHD) can affect brain development. Infants with CHD may experience delays in their neurodevelopment, and this research aims to identify specific risks that could lead to brain injury or hinder healthy brain growth. The study will look at changes in blood flow to the brain during and after surgery, measure DNA from brain cells to detect any damage, and use advanced technology to predict the long-term developmental outcomes for these infants.
To participate in this trial, infants must be diagnosed with specific types of CHD that require treatment within the first six months of life, and they must receive care at the University Hospitals Leuven. Unfortunately, infants with certain genetic conditions or metabolic diseases are not eligible. Families participating can expect to undergo a series of tests and monitoring to help researchers better understand the impact of heart surgery on brain health and ultimately improve follow-up care for these children.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Universitaire Ziekenhuizen Ku Leuven
Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Leuven, Vlaams Brabant, Belgium
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported