Early Detection of Brain Injury After Congenital Heart Surgery in Infants

March 6, 2026 updated by: University Medical Centre Ljubljana

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric Clinic UMC Ljubljana

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1 (single cohort; no control group)
Infants (≤1 year) with congenital heart disease undergoing cardiac surgery requiring extracorporeal circulation.
Other: Observational study: blood analisys, EEG, MRI
Observational study: blood analisys, EEG, MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 24 hours pre-op; 1 hour post-op arrival; 24, 48, 72, 96 hours; and 7 days post-op.
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
Post-op day 0-1 and post-op day 7
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
Post-op week 1-2.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 1. Wernovsky G, Licht DJ. Neurodevelopmental Outcomes in Children With Congenital Heart Disease-What Can We Impact? Pediatr Crit Care Med. 2016 Aug;17(8 Suppl 1):S232-42. 2. Zhu S, Sai X, Lin J, Deng G, Zhao M, Nasser MI, Zhu P. Mechanisms of perioperative brain damage in children with congenital heart disease. Biomed Pharmacother. 2020 Dec;132:110957. 3. Fenton KN, Freeman K, Glogowski K, Fogg S, Duncan KF. The significance of baseline cerebral oxygen saturation in children undergoing congenital heart surgery. Am J Surg. 2005 Aug;190(2):260-3. 4. Hasslacher J, Lehner GF, Harler U, Beer R, Ulmer H, Kirchmair R, Fischer-Colbrie R, Bellmann R, Dunzendorfer S, Joannidis M. Secretoneurin as a marker for hypoxic brain injury after cardiopulmonary resuscitation. Intensive Care Med. 2014 Oct;40(10):1518-27. 5. Wechselberger K, Schmid A, Posod A, Höck M, Neubauer V, Fischer-Colbrie R, Kiechl-Kohlendorfer U, Griesmaier E. Secretoneurin Serum Levels in Healthy Term Neonates and Neonates with Hypoxic-Ischaemic Encephalopathy. Neonatology. 2016;110(1):14-20. 6. Zhang S, Wu M, Peng C, Zhao G, Gu R. GFAP expression in injured astrocytes in rats. Exp Ther Med. 2017 Sep;14(3):1905-1908. 7. Coşkun Çeltik, Betül Acunaş, Naci Öner, Özer Pala,.Neuron-specific enolase as a marker of the severity and outcome of hypoxic ischemic encephalopathy, Brain and Development. 2004;398-402. 8. Snyder-Ramos, S. A., Gruhlke, T., Bauer, H., Bauer, M., Luntz, A. P., Motsch, J., … & Böttiger, B. W. (2004). Cerebral and extracerebral release of protein s100b in cardiac surgical patients. Anaesthesia, 59(4), 344-349. 9. Matuszczak, E., Tylicka, M., Komarowska, M. D., Debek, W. & Hermanowicz, A. Ubiquitin carboxy-terminal hydrolase L1-Physiology and pathology. Cell Biochem. Funct. 38, 533-540 (2020) 10. Kirschen MP, Yehya N, Graham K, Kilbaugh T, Berg RA, Topjian A, Diaz-Arrastia R. Circulating Neurofilament Light Chain Is Associated With Survival After Paediatric Cardiac Arrest. Pediatr Crit Care Me

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120-469/2023-2711-6
  • UKC TP 20240274 (Other Grant/Funding Number: University Medical Center Ljubljana)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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