Congenital Heart Disease (CHD)NCT07424976
Early Detection of Brain Injury After Congenital Heart Surgery in Infants
An observational study of Congenital Heart Disease (CHD) and Hypoxic Encephalopathy, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 days to 1 year
- Conditions the study is for
- Congenital Heart Disease (CHD), Hypoxic Encephalopathy
- What is being tested?
- Observational study: blood analisys, EEG, MRI
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 3 May 2024to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 days to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric Clinic UMC Ljubljana
Who may be able to join
- Infants/children up to 1 year of age with congenital heart disease undergoing surgery requiring extracorporeal blood circulation (cardiopulmonary bypass).
Who cannot join
- Congenital heart disease not requiring extracorporeal circulation during surgery
- Inoperable congenital heart defect
- Hypoxic encephalopathy at birth requiring therapeutic hypothermia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Observational study: blood analisys, EEG, MRI
- Keywords
- Secretoneurin, GFAP, Neuron-specific enolase, S100B, UCHL-1, Neurofilament light chain, MRI, Cardiopulmonary bypass
- Medical subject headings
- Heart Defects, Congenital, Hypoxia, Brain, Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study: blood analisys, EEG, MRIOther
Observational study: blood analisys, EEG, MRI
| Study group | Role | What they receive |
|---|---|---|
| 1 (single cohort; no control group) | Infants (≤1 year) with congenital heart disease undergoing cardiac surgery requiring extracorporeal circulation. Receives: Other: Observational study: blood analisys, EEG, MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Post-op week 1-2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start3 May 2024
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424976
- Sponsor's protocol ID
- 0120-469/2023-2711-6
- Other IDs
- UKC TP 20240274
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Brain Damage in Children With Congenital Heart Disease After Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT07424976
- Acronym / sponsor ID
- 0120-469/2023-2711-6
- Keywords
- Secretoneurin, GFAP, Neuron-specific enolase, S100B, UCHL-1, Neurofilament light chain, MRI, Cardiopulmonary bypass
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 (single cohort; no control group) | – | Other: Observational study: blood analisys, EEG, MRIInfants (≤1 year) with congenital heart disease undergoing cardiac surgery requiring extracorporeal circulation. |
Who may qualify
- Ages
- 10 days to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric Clinic UMC Ljubljana
Key inclusion criteria (1 listed)
- Infants/children up to 1 year of age with congenital heart disease undergoing surgery requiring extracorporeal blood circulation (cardiopulmonary bypass).
Key exclusion criteria (3 listed)
- Congenital heart disease not requiring extracorporeal circulation during surgery
- Inoperable congenital heart defect
- Hypoxic encephalopathy at birth requiring therapeutic hypothermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study: blood analisys, EEG, MRIObservational study: blood analisys, EEG, MRI | Other | 1 (single cohort; no control group) |
Primary outcome
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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background1. 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
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Heart Disease (CHD)
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease (CHD) and Hypoxic Encephalopathy, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07424976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.