Actively Recruiting
Predictive Value of Neurovascular Coupling in Infants With COngenital Heart Disease
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-04-02
200
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 both prenatal and perioperative factors. The main goal of this research project is to focus on peri-operative physiological risk factors in infants with CHD which impair functional brain maturation or elicit brain injury, and subsequently creating a risk model and guidelines for standardized developmental follow-up in this population. PART 1: investigation of cerebral autoregulation and neurovascular coupling The homeostasis in cerebral blood supply regardless of perfusion pressure, is called Cerebral autoregulation (CAR). Neurovascular coupling (NVC) is the phenomenon in which blood supply increases as a result of increased brain activity in a specific area. At different times in the perioperative phase, these regulatory mechanisms will be estimated based on Electroencephalography (EEG) and Near Infrared Spectroscopy (NIRS), in addition to hemodynamic parameters. PART 2: cell-free DNA (cfDNA) extraction. Non-invasive monitoring of neuronal degeneration can be performed using cfDNA extraction techniques. Serial measurements of neuronal cfDNA will be used to determine whether and when this neuronal damage has occurred. PART 3: Prognosis and outcome. These risk factors, supplemented with demographic factors and medications administered, will be combined in an Artificial Intelligence-driven model, thus establishing a risk model for neurodevelopmental outcome. This model will be compared to the current standard-of-care, both structural imaging (ultrasound and MRI) and a clinical developmental assessment at 9 and 24 months of age (Bayley Scales of Infant Development-III).
CONDITIONS
Official 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 within 6 months of age, including 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 the University Hospitals Leuven
You will not qualify if you...
- Presence of 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
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
L
Liselotte Van Loo, MD
CONTACT
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
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