Skip to main content
OpenTrials
Completed

NCT Number: NCT05712330

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, 80000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non invasive ventilation samples

Other

machine samples for bacterial culture will be performed

patient samples

Other

Patient samples for sputum culture

parent questionnaire

Other

parent questionnaire

Primary outcomes

  1. number of hospitalization days for respiratory exacerbations with germs identical to protocol samples

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: AVNIR

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 3, 2023
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.