UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
NCT Number: NCT06190210
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).
Interested in participating?
Request InfoUp to 6 month
All sexes
Observational
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pre-, per- and postoperative electroencephalography
Other names: EEG
Pre-, Per- and Postoperative near-infrared spectroscopy returning regional cerebral oxygen saturation
Other names: NIRS
CfDNA which is characterized based on methylation patterns to determine the tissue of origin
Other names: cfDNA
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
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
Interested in participating?
Request InfoUniversitaire Ziekenhuizen KU Leuven
Other
The Impact of Perioperative Neurovascular Coupling on Outcome in Infants With Congenital Heart Disease.
Acronym: NICO
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.
Published trials that share one or more normalized conditions with this study.
NCT05997680
Cardiovascular Abnormalities, Cardiovascular Diseases
Montreal, Quebec, Canada
View Trial DetailsNCT03882788
Anesthesia; Adverse Effect, Cardiovascular Abnormalities
Palo Alto, California, United States
View Trial DetailsNCT03360370
Cardiovascular Abnormalities, Cardiovascular Diseases
Lille, France
View Trial DetailsNCT06575270
Cardiovascular Abnormalities, Cardiovascular Diseases
New York, United States
View Trial Details