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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05712330

Acronym

AVNIR

Enrollment

Registered

2023-02-03

Start date

2023-01-24

Completion date

2025-05-22

Last updated

2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Invasive Ventilation, Respiratory Bacterial Infection, Spinal Muscular Atrophy

Keywords

non invasive ventilation, Spinal Muscular Atrophy, Respiratory Bacterial Infection

Brief 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.

Interventions

OTHERnon invasive ventilation samples

machine samples for bacterial culture will be performed

OTHERpatient samples

Patient samples for sputum culture

OTHERparent questionnaire

parent questionnaire

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Years

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

Design outcomes

Primary

Measure	Time frame
number of hospitalization days for respiratory exacerbations with germs identical to protocol samples	one year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026