Congenital Heart DiseaseNICONCT06190210
Predictive Value of Neurovascular Coupling in Infants With COngenital Heart Disease
An observational study of Congenital Heart Disease and Neurodevelopmental Disorders, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Congenital Heart Disease, Neurodevelopmental Disorders, Electroencephalography
- What is being tested?
- electroencephalography, Near-Infrared Spectroscopy and neuronal cell-free DNA
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2023to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Neonates with congenital heart disease requiring a first intervention within the first 6 months of life
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Liselotte Van Loo, MD, +3216346057, liselotte.vanloo@uzleuven.be
Katrien Jansen, MD, PhD
About this study
Official title: 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.
Read more
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
- Being tested
- electroencephalography, Near-Infrared Spectroscopy, neuronal cell-free DNA
- Keywords
- Congenital heart disease, Neurodevelopment, Neuromonitoring, Biomarkers, EEG, NIRS
- Medical subject headings
- Heart Defects, Congenital, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalographyDiagnostic test
Also called EEG
Pre-, per- and postoperative electroencephalography
Near-Infrared SpectroscopyDiagnostic test
Also called NIRS
Pre-, Per- and Postoperative near-infrared spectroscopy returning regional cerebral oxygen saturation
neuronal cell-free DNADiagnostic test
Also called cfDNA
CfDNA which is characterized based on methylation patterns to determine the tissue of origin
| Study group | Role | What they receive |
|---|---|---|
| Congenital heart disease | Neonates with congenital heart disease necessitating treatment before the age of 6 months, either surgical or through cardiac catheterization Receives: Diagnostic Test: electroencephalography; Diagnostic Test: Near-Infrared Spectroscopy; Diagnostic Test: neuronal cell-free DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: +- 1 week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Dec 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190210
- Sponsor's protocol ID
- S68131
- Acronym
- NICO
- Status last verified
- Mar 2025
- First submitted
- 15 Dec 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Perioperative Neurovascular Coupling on Outcome in Infants With Congenital Heart Disease.
- ClinicalTrials.gov ID
- NCT06190210
- Acronym / sponsor ID
- NICO / S68131
- Conditions
- Congenital Heart Disease, Neurodevelopmental Disorders, Electroencephalography, Near-Infrared Spectroscopy, Biomarkers
- Keywords
- Congenital heart disease, Neurodevelopment, Neuromonitoring, Biomarkers, EEG, NIRS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Congenital heart disease | – | Diagnostic Test: electroencephalography, Diagnostic Test: Near-Infrared Spectroscopy, Diagnostic Test: neuronal cell-free DNANeonates with congenital heart disease necessitating treatment before the age of 6 months, either surgical or through cardiac catheterization |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates with congenital heart disease requiring a first intervention within the first 6 months of life
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroencephalographyAlso: EEGPre-, per- and postoperative electroencephalography | Diagnostic test | Congenital heart disease |
| Near-Infrared SpectroscopyAlso: NIRSPre-, Per- and Postoperative near-infrared spectroscopy returning regional cerebral oxygen saturation | Diagnostic test | Congenital heart disease |
| neuronal cell-free DNAAlso: cfDNACfDNA which is characterized based on methylation patterns to determine the tissue of origin | Diagnostic test | Congenital heart disease |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Neurodevelopmental Disorders, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liselotte Van Loo, MD (+3216346057, liselotte.vanloo@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical neurological development measured with Bayley Scale of Infant Development (time frame: 9 months, 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.