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RECRUITING
NCT06190210

Predictive Value of Neurovascular Coupling in Infants With COngenital Heart Disease

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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 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).

Official title: The Impact of Perioperative Neurovascular Coupling on Outcome in Infants With Congenital Heart Disease.

Key Details

Gender

All

Age Range

Any - 6 Months

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2023-12-01

Completion Date

2027-09-30

Last Updated

2025-04-02

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

electroencephalography

Pre-, per- and postoperative electroencephalography

DIAGNOSTIC_TEST

Near-Infrared Spectroscopy

Pre-, Per- and Postoperative near-infrared spectroscopy returning regional cerebral oxygen saturation

DIAGNOSTIC_TEST

neuronal cell-free DNA

CfDNA which is characterized based on methylation patterns to determine the tissue of origin

Locations (1)

UZ Leuven

Leuven, Vlaams-Brabant, Belgium