Early Detection of Brain Injury After Congenital Heart Surgery in Infants

NCT07424976 | Enrolling By Invitation

• 2 other identifiers: 0120-469/2023-2711-6UKC TP 20240274
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease (CHD); Hypoxic Encephalopathy

Keywords

Secretoneurin; GFAP; Neuron-specific enolase; S100B; UCHL-1; Neurofilament light chain; MRI; Cardiopulmonary bypass

Outcome Measures

Primary Outcomes (3)

• Concentration of serum brain injury biomarker concentrations (ELISA panel)

  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

  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)

  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.

Study Arms (1)

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

Interventions

Observational study: blood analisys, EEG, MRI OTHER

Observational study: blood analisys, EEG, MRI

1 (single cohort; no control group)

Eligibility Criteria

• Age: 10 Days - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric Clinic UMC Ljubljana

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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• 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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Heart Defects, Congenital; Hypoxia, Brain; Charcot-Marie-Tooth disease, Type 1F

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: May 3, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-02

Locations

SL (1)