NCT05712330

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non Invasive Ventilation
• Spinal Muscular Atrophy
• Respiratory Bacterial Infection

Interventions

Type	Name	Description
OTHER	non invasive ventilation samples	machine samples for bacterial culture will be performed
OTHER	patient samples	Patient samples for sputum culture
OTHER	parent questionnaire	parent questionnaire

Timeline

• Start date: 2023-01-24
• Primary completion: 2024-08-24
• Completion: 2025-05-22
• First posted: 2023-02-03
• Last updated: 2025-05-28

Locations

1 site across 1 country: France