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NCT Number: NCT06190210

Predictive Value of Neurovascular Coupling 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).

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Key information

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

Location contact

Anneleen Dereymaeker, MD, PhD

SUB_INVESTIGATOR

Bjorn Cools, MD, PhD

SUB_INVESTIGATOR

Katrien Jansen, MD, PhD

PRINCIPAL_INVESTIGATOR

Liselotte Van Loo, MD

CONTACT

[email protected]

+3216346057

Liselotte Van Loo, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electroencephalography

Diagnostic Test

Pre-, per- and postoperative electroencephalography

Other names: EEG

Near-Infrared Spectroscopy

Diagnostic Test

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

Other names: NIRS

neuronal cell-free DNA

Diagnostic Test

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

Other names: cfDNA

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Liselotte Van Loo, MD

CONTACT

[email protected]

+3216346057

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: NICO

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 5, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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