Early Detection of Brain Injury After Congenital Heart Surgery in Infants

Enrolling by invitation

Conditions studied: Congenital Heart Disease (CHD), Hypoxic Encephalopathy

In brief

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.

Key facts

Study ID

NCT07424976

Run by

University Medical Centre Ljubljana

People needed

30

Starts

2024-05-03

Expected to finish

2026-09-01

Last updated by the study team

2026-03-10

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants/children up to 1 year of age with congenital heart disease undergoing surgery requiring extracorporeal blood circulation (cardiopulmonary bypass).

You may not qualify if…

• Congenital heart disease not requiring extracorporeal circulation during surgery
• Inoperable congenital heart defect
• Hypoxic encephalopathy at birth requiring therapeutic hypothermia

Where it is running

• University Medical Center — Ljubljana, Slovenia

Full record on ClinicalTrials.gov

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