Back to resultsExploratory Study of Respiratory Bacterial Infections or Superinfections and Colonizations in Patients With Spinal Muscular Atrophy Under NIV (AVNIR)
Primary Purpose
Non Invasive Ventilation, Spinal Muscular Atrophy, Respiratory Bacterial Infection
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
non invasive ventilation samples
patient samples
parent questionnaire
Sponsored by
About this trial
This is an interventional screening trial for Non Invasive Ventilation focused on measuring non invasive ventilation, Spinal Muscular Atrophy, Respiratory Bacterial Infection
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Universitaire d'AmiensRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
non invasive ventilation
Arm Description
SMA patients with NIV
Outcomes
Primary Outcome Measures
number of hospitalization days for respiratory exacerbations with germs identical to protocol samples
Secondary Outcome Measures
Full Information
NCT ID
NCT05712330
First Posted
January 26, 2023
Last Updated
January 26, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05712330
Brief Title
Exploratory Study of Respiratory Bacterial Infections or Superinfections and Colonizations in Patients With Spinal Muscular Atrophy Under NIV
Acronym
AVNIR
Official Title
Exploratory Study of Respiratory Bacterial Infections or Superinfections and Colonizations in Patients With Spinal Muscular Atrophy Under NIV
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Invasive Ventilation, Spinal Muscular Atrophy, Respiratory Bacterial Infection
Keywords
non invasive ventilation, Spinal Muscular Atrophy, Respiratory Bacterial Infection
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
non invasive ventilation
Arm Type
Experimental
Arm Description
SMA patients with NIV
Intervention Type
Other
Intervention Name(s)
non invasive ventilation samples
Intervention Description
machine samples for bacterial culture will be performed
Intervention Type
Other
Intervention Name(s)
patient samples
Intervention Description
Patient samples for sputum culture
Intervention Type
Other
Intervention Name(s)
parent questionnaire
Intervention Description
parent questionnaire
Primary Outcome Measure Information:
Title
number of hospitalization days for respiratory exacerbations with germs identical to protocol samples
Time Frame
one year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud BECOURT, MD
Phone
03.22.08.83.71
Email
becourt.arnaud@chu-amiens.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire d'Amiens
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud BECOURT, MD
Phone
03.22.08.83.71
Email
becourt.arnaud@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Manon CARLIER, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exploratory Study of Respiratory Bacterial Infections or Superinfections and Colonizations in Patients With Spinal Muscular Atrophy Under NIV
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