Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07424976

Early Detection of Brain Injury After Congenital Heart Surgery in Infants

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Congenital Heart Disease (CHD) Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Charcot-Marie-Tooth disease, Type 1F Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hypoxia Hypoxia, Brain Hypoxic Encephalopathy Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

10 day–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational study: blood analisys, EEG, MRI

Other

Observational study: blood analisys, EEG, MRI

Primary outcomes

  1. Concentration of serum brain injury biomarker concentrations (ELISA panel)

    Time frame: 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.

  2. Number of Participants with postoperative EEG abnormalities

    Time frame: Post-op day 0-1 and post-op day 7

    EEG findings assessed within the first 24 hours and on postoperative day 7

  3. Presence and types of intracranial injuries seen on brain MRI (subset)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Early Detection of Brain Damage in Children With Congenital Heart Disease After Cardiovascular Surgery

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Mar 10, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.