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Enrolling by invitation NCT07424976

Early Detection of Brain Injury After Congenital Heart Surgery in Infants

— Observational Congenital Heart Disease (CHD) Hypoxic Encephalopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational study: blood analisys, EEG, MRI.
Who it may be relevant to
Registry conditions: Congenital Heart Disease (CHD), Hypoxic Encephalopathy. Basic parameters: 10 Days — 1 year · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Observational study: blood analisys, EEG, MRI
    Observational study: blood analisys, EEG, MRI

Primary outcome measures

  • 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.]
  • Number of Participants with postoperative EEG abnormalities [Time frame: 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Slovenia · 1 center
  • University Medical Center — Ljubljana

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,

Identifiers

NCT: NCT07424976 · 0120-469/2023-2711-6 · UKC TP 20240274

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗