Predictive Value of Neurovascular Coupling in Infants With COngenital Heart Disease

NCT ID: NCT06190210

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2027-09-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Congenital heart disease

Neonates with congenital heart disease necessitating treatment before the age of 6 months, either surgical or through cardiac catheterization

electroencephalography

Intervention Type: DIAGNOSTIC_TEST

Pre-, per- and postoperative electroencephalography

Near-Infrared Spectroscopy

Intervention Type: DIAGNOSTIC_TEST

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

neuronal cell-free DNA

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

electroencephalography

Pre-, per- and postoperative electroencephalography

Intervention Type: DIAGNOSTIC_TEST

Near-Infrared Spectroscopy

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

Intervention Type: DIAGNOSTIC_TEST

neuronal cell-free DNA

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

EEG; NIRS; cfDNA

Eligibility Criteria

Inclusion Criteria

• CHD warranting a first percutaneous or surgical intervention in the first 6 months, including but not limited to transposition of the great arteries (TGA), univentricular heart (UVH), Tetralogy of Fallot (TOF), coarctation of the aorta (CoA), total abnormal pulmonary venous drainage (TAPVU), Common arterial trunc (TA), large patent ductus arteriosus (PDA) or VSD and AVSD for which treatment is necessary within the first 6 months of life.
• Treatment provided at the University Hospitals Leuven.

Exclusion Criteria

• Syndromes or proven genetic conditions which are associated with neurological impairment
• CHD warranting treatment after 6 months of life
• Suspected or proven metabolic diseases
• No parental/guardian consent

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Liselotte Van Loo, MD

Role: CONTACT

liselotte.vanloo@uzleuven.be

+3216346057

Facility Contacts

Liselotte Van Loo, MD

Role: primary

liselotte.vanloo@uzleuven.be

+3216346057

Other Identifiers

S68131

Identifier Type: -

Identifier Source: org_study_id