Clinical Trial

Early Detection of Brain Injury After Congenital Heart Surgery in Infants

Enrolling by Invitation
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Record status
This record was last updated March 10, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-13.
Trial Details
NCT Number NCT07424976
Lead Sponsor University Medical Centre Ljubljana
Conditions Congenital Heart Disease (CHD), Hypoxic Encephalopathy
Enrollment 30 participants
Start Date 2024-05-03
Primary Completion 2026-06 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-10