Predictive Value of Neurovascular Coupling in Infants With COngenital Heart Disease

NCT06190210 | Recruiting

• 1 other identifier: S68131
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Congenital heart disease; Neurodevelopment; Neuromonitoring; Biomarkers; EEG; NIRS

Outcome Measures

Primary Outcomes (2)

• Clinical neurological development measured with Bayley Scale of Infant Development

  Rate of abnormal clinical neurodevelopment measured with the Bayley Scale of Infant Development (BSID-III): range 50-150, mean 100, SD 15

  9 months, 24 months

• Brain MRI structural brain abnormalities

  Incidence of patients with normal brain development vs rate of bleeding/stroke visualized on brain MRI Differences in total brain volume and cerebellar volume in patients with congenital heart disease

  +- 1 week postoperative

Study Arms (1)

Congenital heart disease

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

Diagnostic Test: electroencephalography; Diagnostic Test: Near-Infrared Spectroscopy; Diagnostic Test: neuronal cell-free DNA

Interventions

electroencephalography DIAGNOSTIC_TEST

Pre-, per- and postoperative electroencephalography

Also known as: EEG

Congenital heart disease

Near-Infrared Spectroscopy DIAGNOSTIC_TEST

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

Also known as: NIRS

Congenital heart disease

neuronal cell-free DNA DIAGNOSTIC_TEST

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

Also known as: cfDNA

Congenital heart disease

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates with congenital heart disease requiring a first intervention within the first 6 months of life

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

methylation patterns of neuronal cell-free DNA

MeSH Terms

Conditions

Heart Defects, Congenital; Neurodevelopmental Disorders

Interventions

Electroencephalography; Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Diagnostic Imaging; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Liselotte Van Loo, MD

CONTACT

+3216346057; liselotte.vanloo@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 5, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)