Predictive Value of Neurovascular Coupling in Infants With COngenital Heart Disease

Congenital Heart Disease Clinical Trial

— NICO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06190210
• Other study ID #: S68131
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: January 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Liselotte Van Loo, MD
• Phone: +3216346057
• Email: liselotte.vanloo[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2027
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• electroencephalography
Pre-, per- and postoperative electroencephalography
• Near-Infrared Spectroscopy
Pre-, Per- and Postoperative near-infrared spectroscopy returning regional cerebral oxygen saturation
• neuronal cell-free DNA
CfDNA which is characterized based on methylation patterns to determine the tissue of origin

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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