NCT05712330Completed
Exploratory Study of Respiratory Bacterial Infections or Superinfections and Colonizations in Patients With Spinal Muscular Atrophy Under NIV
Source: ClinicalTrials.gov · Last updated 28 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 26 Jan 2023
- Start date
- Jan 2023
- Primary completion date
- Aug 2024
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Diseases
- Spinal muscular atrophy
- NCT number
- NCT05712330
What you commit to
- Study type: Interventional
- Participants enrolled: 8
- From Jan 2023 to the primary completion date, Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Invasive ventilation on tracheotomy
- No ventilation
- Other treatment than Nusinersen or no treatment
- Parental refusal to participate in the study
Who the study is looking for
- 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
Age in the registry: - to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire d'Amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.