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

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Non Invasive Ventilation; Respiratory Bacterial Infection; Spinal Muscular Atrophy

Treatments: Other: non invasive ventilation samples; Other: patient samples; Other: parent questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT05712330

PI2022_843_0095

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Invasive ventilation on tracheotomy
• No ventilation
• Other treatment than Nusinersen or no treatment
• Parental refusal to participate in the study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

non invasive ventilation

Experimental group

Description:

SMA patients with NIV

Treatment:

Other: parent questionnaire

Other: patient samples

Other: non invasive ventilation samples