Myocardial Changes in Pediatric Guillain-Barré Syndrome
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorAssiut University
About this trial
This prospective cohort study aims to identify and characterize cardiac changes including electrocardiographic, echocardiographic, and biochemical abnormalities in pediatric patients with Guillain-Barré syndrome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 1 month to 18 years
Confirmed diagnosis of Guillain-Barré syndrome
Onset of neurological symptoms within 2 weeks prior to hospital presentation
No pre-existing cardiac disease
Disqualifiers
Pre-existing congenital or acquired heart disease
Pre-existing neuromuscular disorders or hereditary peripheral neuropathies
Incomplete cardiac workup (inability to perform ECG, echocardiography, and cardiac biomarker assessment)
Loss to follow-up before hospital discharge
Trial population
Pediatric patients aged 1 month to 18 years with confirmed Guillain-Barré syndrome admitted to Assiut University Children's Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
72 Participants
are grouped into 1 trial groupGroup A: Single cohort: Pediatric patients with Guillain-Barré syndrome
Trial outcomes
Primary outcomes
1
Prevalence of cardiac abnormalities
Proportion of patients with any cardiac abnormality detected by electrocardiography, echocardiography, or elevated cardiac biomarkers (troponin I or CK-MB).
Time frame
BaselineSecondary outcomes
1
Prevalence of electrocardiographic abnormalities
Proportion of patients with ECG abnormalities including rhythm disturbances, ST-segment changes, T-wave abnormalities, or conduction blocks.
Time frame
Baseline2
Mean left ventricular ejection fraction (LVEF)
Mean left ventricular ejection fraction percentage measured by echocardiography.
Time frame
Baseline3
Prevalence of elevated cardiac troponin I
Proportion of patients with elevated serum cardiac troponin I levels.
Time frame
Baseline4
Prevalence of cardiac abnormalities at follow-up
Proportion of patients with any cardiac abnormality detected by electrocardiography, echocardiography, or elevated cardiac biomarkers at 3-month follow-up.
Time frame
At 3 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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