Exploratory Study of Respiratory Bacterial Infections or Superinfections and Colonizations in Patients With Spinal Muscular Atrophy Under NIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- number of hospitalization days for respiratory exacerbations with germs identical to protocol samples
研究概览
简要总结
SMA (Spinal Muscular Atrophy) is a rare neuromuscular disease characterized by motoneuron damage. Symptoms consist of respiratory involvement with numerous respiratory infections and eventually respiratory failure, for which NIV (Non Invasive Ventilation) is often used. Ventilation machines are in close contact with the respiratory tract of patients. They contain heated water to humidify the circuit. These humid and warm environments are conducive to the development of bacteria such as Pseudomonas aeruginosa. In this context, it is interesting to look for the presence or absence of bacteria, in comparison with the respiratory ecology of the patients. The aim is to highlight the microbiological role of NIV on the occurrence of respiratory bacterial infections or secondary infections in patients with SMA. To do this, samples are taken from the machines, and ECBCs are performed on patients during respiratory physiotherapy sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AMS (previous diagnosis or new diagnosis during the inclusion period)
- •Age from 0 to 12 years old
- •Nusinersen treatment
- •Benefiting from a NIV
- •Current monitoring at the University Hospital of Amiens
排除标准
- •Invasive ventilation on tracheotomy
- •No ventilation
- •Other treatment than Nusinersen or no treatment
- •Parental refusal to participate in the study
结局指标
主要结局
number of hospitalization days for respiratory exacerbations with germs identical to protocol samples
时间窗: one year
次要结局
未报告次要终点
