Actively Recruiting
The Impact of Perioperative Neurovascular Coupling on Outcome in Infants With Congenital Heart Disease
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-04-02
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on infants with congenital heart disease (CHD), who are at higher risk for delayed brain development. The study aims to understand how perioperative physiological factors affect brain function and injury in these infants. Researchers plan to create a risk model and guidelines for standardized developmental follow-up by examining multiple factors including brain blood flow regulation and neuronal damage. The study involves three main parts: first, monitoring brain blood flow regulation and brain activity using electroencephalography (EEG) and near-infrared spectroscopy (NIRS) before, during, and after heart treatment. Second, measuring neuronal cell-free DNA (cfDNA) to non-invasively detect brain cell damage over time. Lastly, using an AI-driven model that combines physiological, demographic, and medication data to predict neurodevelopmental outcomes, which will be compared with current imaging and clinical assessments. Participants will undergo EEG and NIRS monitoring around the time of their heart surgery or catheterization. Brain MRI scans will be done shortly after surgery to observe structural changes. Neurodevelopment will be assessed at 9 and 24 months using the Bayley Scales of Infant Development. The study will track brain function, injury markers, and developmental progress to better understand risks and improve follow-up care for infants with CHD.
CONDITIONS
Brief Title
Predictive Value of Neurovascular Coupling in Infants With COngenital Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants with congenital heart disease needing first surgery or catheter treatment before 6 months of age
- Includes conditions like transposition of the great arteries, univentricular heart, Tetralogy of Fallot, coarctation of the aorta, total abnormal pulmonary venous drainage, common arterial trunk, large patent ductus arteriosus, ventricular septal defect, or atrioventricular septal defect
- Treatment must be provided at University Hospitals Leuven
You will not qualify if you...
- Genetic syndromes or confirmed genetic conditions associated with neurological impairment
- Congenital heart disease requiring treatment after 6 months of age
- Suspected or confirmed metabolic diseases
- Lack of parental or guardian consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From preoperative period through approximately 1 week postoperative
Participants undergo pre-, peri-, and postoperative diagnostic tests including electroencephalography, near-infrared spectroscopy, and neuronal cell-free DNA analysis.
Multiple visits around the surgical or catheter treatment period
Duration - Up to 24 months after treatment
Participants are monitored for neurological development using the Bayley Scale of Infant Development at 9 and 24 months after treatment.
2 visits (at 9 and 24 months post-treatment)
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
L
Liselotte Van Loo, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here