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Predictive Value of Neurovascular Coupling in Infants With COngenital Heart Disease

NCT06190210 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-04-02

No results posted yet for this study

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).

Conditions

  • Congenital Heart Disease
  • Neurodevelopmental Disorders
  • Electroencephalography
  • Near-Infrared Spectroscopy
  • Biomarkers

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

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06190210 on ClinicalTrials.gov