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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05712330

Collaborator

(none)

Enrollment

Location

Arm

19.3

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Invasive Ventilation Spinal Muscular Atrophy Respiratory Bacterial Infection	Other: non invasive ventilation samples Other: patient samples Other: parent questionnaire	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jan 24, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: non invasive ventilation SMA patients with NIV	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

Arm

Intervention/Treatment

Experimental: non invasive ventilation

SMA patients with NIV

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

Outcome Measures

Primary Outcome Measures

number of hospitalization days for respiratory exacerbations with germs identical to protocol samples [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 12 Years

Sexes Eligible for Study:

All

Accepts 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