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临床试验/NCT05712330
NCT05712330已完成不适用

Exploratory Study of Respiratory Bacterial Infections or Superinfections and Colonizations in Patients With Spinal Muscular Atrophy Under NIV

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年1月24日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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