Comparison of Intravenous Immunoglobulin and Plasma Exchange in Treatment of Mechanically Ventilated Children With Guillain Barre Syndrome. A Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Duration of mechanical ventilation
研究概览
简要总结
Comparing whether intravenous immune globulin or plasma exchange is superior in treating mechanically ventilated children with Guillain Barre syndrome.
详细描述
Children with Guillain Barre syndrome (GBS) admitted to PICU at Mansoura University Children Hospital, Mansoura, Egypt with the need for mechanical ventilation were prospectively enrolled in the study.
Cases were diagnosed according to clinical criteria. The decisions to initiate, wean and terminate mechanical ventilation were made independently by the attending consultant in accordance with the unit guidelines.
Outcome variables measured were duration of mechanical ventilation, length of PICU stay and ability to walk unaided 4 weeks after PICU discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: children from 1 month - 18 years old
- •Clinical diagnosis of Guillain Barre syndrome
- •Requirement of mechanical ventilation
排除标准
- •Need for mechanical ventilation beyond 14 days from disease onset
- •Child receiving IVIG or PE prior to enrollment
研究组 & 干预措施
IVIG group
20 children randomized to receive IVIG for 5 days at a dose of 0.4 g/kg/day
干预措施: IVIG (Drug)
Plasma Exchange
21 children randomized to receive 5 sessions of 1 volume plasma exchange per day for 5 consecutive days
干预措施: Plasma Exchange (Procedure)
结局指标
主要结局
Duration of mechanical ventilation
时间窗: 21 days (average)
How many days did the mechanical ventilation continue
次要结局
- PICU stay(28 days (average))
- Ability to walk(4 weeks from PICU discharge)