Predictive Value of Neurovascular Coupling in Infants With COngenital Heart Disease (NICO)

March 27, 2025 updated by: Universitaire Ziekenhuizen KU Leuven

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
        • Contact:
          • Katrien Jansen, MD, PhD
        • Contact:
          • Liselotte Van Loo, MD
        • Contact:
          • Anneleen Dereymaeker, MD, PhD
        • Contact:
          • Bjorn Cools, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Pre-, per- and postoperative electroencephalography
Other Names:
  • EEG
Diagnostic test: Near-Infrared Spectroscopy
Pre-, Per- and Postoperative near-infrared spectroscopy returning regional cerebral oxygen saturation
Other Names:
  • NIRS
Diagnostic test: neuronal cell-free DNA
CfDNA which is characterized based on methylation patterns to determine the tissue of origin
Other Names:
  • cfDNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical neurological development measured with Bayley Scale of Infant Development
Time Frame: 9 months, 24 months
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
Time Frame: +- 1 week postoperative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S68131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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