Congenital Heart Disease (CHD), Hypoxic Encephalopathy
Conditions
Keywords
Secretoneurin, GFAP, Neuron-specific enolase, S100B, UCHL-1, Neurofilament light chain, MRI, Cardiopulmonary bypass
Brief summary
Infants with congenital heart disease undergoing cardiac surgery with extracorporeal circulation are at risk for perioperative hypoxic-ischaemic brain injury. This prospective, single-centre observational cohort study will evaluate perioperative dynamics of serum biomarkers of neuronal, glial, and axonal injury and relate biomarker patterns to postoperative EEG changes and brain MRI findings, aiming to improve early detection of brain injury and identify children at higher risk of hypoxic encephalopathy.
Detailed description
This prospective observational study will enrol 30 children up to 1 year of age with congenital heart disease requiring surgery with extracorporeal circulation at a single paediatric intensive care centre. After parental/guardian consent, peripheral blood will be collected for ELISA measurement of secretoneurin, GFAP, neuron-specific enolase, S100B, UCHL-1, neurofilament light chain, and total tau at the following time points: within 24 hours preoperatively; 1 hour after arrival from the operating theatre; and 24, 48, 72, 96 hours and 7 days postoperatively. All participants will undergo EEG within the first 24 hours and on postoperative day 7. Between postoperative week 1 and week 2, 15 participants will undergo brain MRI under sedation or general anaesthesia. Perioperative and postoperative clinical variables will be abstracted (e.g., cardiopulmonary bypass duration, major artery clamp duration, inotrope/vasoactive support, arrhythmias, and markers of organ hypoperfusion including lactate and regional oxygen saturation). Associations between biomarker trajectories and EEG/MRI evidence of brain injury will be assessed using repeated-measures modelling; ROC analyses will explore biomarker thresholds where applicable.
Interventions
OTHERObservational study: blood analisys, EEG, MRI
Observational study: blood analisys, EEG, MRI
Sponsors
University Medical Centre Ljubljana
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Days to 1 Years
Healthy volunteers
No
Inclusion criteria
* Infants/children up to 1 year of age with congenital heart disease undergoing surgery requiring extracorporeal blood circulation (cardiopulmonary bypass).
Exclusion criteria
* Congenital heart disease not requiring extracorporeal circulation during surgery * Inoperable congenital heart defect * Hypoxic encephalopathy at birth requiring therapeutic hypothermia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of serum brain injury biomarker concentrations (ELISA panel) | Within 24 hours pre-op; 1 hour post-op arrival; 24, 48, 72, 96 hours; and 7 days post-op. | Serum concentrations of secretoneurin, GFAP, NSE, S100B, UCHL-1, neurofilament light chain, and total tau measured in peripheral blood. |
| Number of Participants with postoperative EEG abnormalities | Post-op day 0-1 and post-op day 7 | EEG findings assessed within the first 24 hours and on postoperative day 7 |
| Presence and types of intracranial injuries seen on brain MRI (subset) | Post-op week 1-2. | Presence/type/frequency of brain MRI findings performed in a subset of 15 participants between postoperative week 1 and week 2 |
Countries
Slovenia
Outcome results
None listed