Myocardial Changes in Pediatric Patients With Guillain-Barré Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 72
- Primary Endpoint
- Prevalence of cardiac abnormalities
Study Overview
Brief Summary
This prospective cohort study aims to identify and characterize cardiac changes including electrocardiographic, echocardiographic, and biochemical abnormalities in pediatric patients with Guillain-Barré syndrome.
Detailed Description
Guillain-Barré syndrome can be associated with cardiac autonomic dysfunction and myocardial involvement. This observational study will include pediatric patients (1 month to 18 years) with confirmed Guillain-Barré syndrome.
Participants will undergo electrocardiography, echocardiography, and cardiac biomarker assessment at hospital admission and at 3-month follow-up.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Month to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Written informed consent from parents or legal guardians
Exclusion Criteria
- •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
Arms & Interventions
Single cohort: Pediatric patients with Guillain-Barré syndrome
Pediatric patients with confirmed Guillain-Barré syndrome who will undergo cardiac evaluation at admission and at 3-month follow-up.
Outcomes
Primary Outcomes
Prevalence of cardiac abnormalities
Time Frame: Baseline
Proportion of patients with any cardiac abnormality detected by electrocardiography, echocardiography, or elevated cardiac biomarkers (troponin I or CK-MB).
Secondary Outcomes
- Prevalence of electrocardiographic abnormalities(Baseline)
- Mean left ventricular ejection fraction (LVEF)(Baseline)
- Prevalence of elevated cardiac troponin I(Baseline)
- Prevalence of cardiac abnormalities at follow-up(At 3 months)
- Mean left ventricular ejection fraction at follow-up(At 3 months)
Investigators
Maria Magdy Monir
Resident Physician, Department of Pediatrics
Assiut University