Actively Recruiting

Age: 0 - 6Months
All Genders
NCT06190210

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

Age: 0 - 6Months
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

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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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