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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Congenital heart disease | Neonates with congenital heart disease necessitating treatment before the age of 6 months, either surgical or through cardiac catheterization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electroencephalography | Diagnostic Test | Pre-, per- and postoperative electroencephalography |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Neonates with congenital heart disease requiring a first intervention within the first 6 months of life
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liselotte Van Loo, MD | Contact | +3216346057 | liselotte.vanloo@uzleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
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methylation patterns of neuronal cell-free DNA
| Near-Infrared Spectroscopy | Diagnostic Test | Pre-, Per- and Postoperative near-infrared spectroscopy returning regional cerebral oxygen saturation |
|
|
| neuronal cell-free DNA | Diagnostic Test | CfDNA which is characterized based on methylation patterns to determine the tissue of origin |
|
|
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D065886 | Neurodevelopmental Disorders |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D003952 | Diagnostic Imaging |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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