Evaluation of efficacy of inhaled Amikacin in prevention of Ventilator Associated Pneumonia in children aged one month to 18 years: An open Labelled Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Incidence of VAP after the five-day course of inhaled Amikacin
研究概览
简要总结
All mechanically ventilated children aged 1 months to 18 years old admitted to PICU will be enrolled after randomization and informed consent as per inclusion and exclusion criteria. In intervention arm inhaled amikacin will be given at 20 mg/kg once a day for days along with standard care for prevention of ventilator assocaited pneumonia. In comparator arm only standard care for prevention of ventilator assocaited pneumonia will be given. All enrolled children will be assessed daily for development of ventilator associated pneumina as per CDC and MCPIS score daily till day 7 of enrolment. For secondary outcome child will be followed till discharge or day 28 which ever is earlier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Mechanically ventilated children between the ages of one month.
- •18 years of age admitted to PICU, Department of Paediatrics, AIIMS Rishikesh.
排除标准
- •Already on invasive mechanical ventilation for more than 24 hours
- •Children who received invasive mechanical ventilation within the previous seven days
- •Severe acute kidney injury without renal replacement therapy, chronic kidney disease 4.Children scheduled for extubation within the next 24 hours.
结局指标
主要结局
Incidence of VAP after the five-day course of inhaled Amikacin
时间窗: 7 days
次要结局
- •Duration of mechanical ventilation, PICU stay, and antibiotic therapy in days(•Proportion of children getting successful extubation)
研究者
Neethu Ravi
AIIMS, Rishikesh