Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UKC TP 20240274 | Other Grant/Funding Number | University Medical Center Ljubljana |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 (single cohort; no control group) | Infants (≤1 year) with congenital heart disease undergoing cardiac surgery requiring extracorporeal circulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study: blood analisys, EEG, MRI | Other | Observational study: blood analisys, EEG, MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Pediatric Clinic UMC Ljubljana
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D002534 | Hypoxia, Brain |
| C537987 | Charcot-Marie-Tooth disease, Type 1F |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
plasma
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |