Myocardial Changes in Pediatric Patients With Guillain-Barré Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Prevalence of cardiac abnormalities
研究概览
简要总结
This prospective cohort study aims to identify and characterize cardiac changes including electrocardiographic, echocardiographic, and biochemical abnormalities in pediatric patients with Guillain-Barré syndrome.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Prevalence of cardiac abnormalities
时间窗: Baseline
Proportion of patients with any cardiac abnormality detected by electrocardiography, echocardiography, or elevated cardiac biomarkers (troponin I or CK-MB).
次要结局
- 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)
研究者
Maria Magdy Monir
Resident Physician, Department of Pediatrics
Assiut University