Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06190210
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-15
Brief Title:
Predictive Value of Neurovascular Coupling in Infants With COngenital Heart Disease
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
The Impact of Perioperative Neurovascular Coupling on Outcome in Infants With Congenital Heart Disease
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NICO
Brief 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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None