Non Invasive VentilationAVNIRNCT05712330
Exploratory Study of Respiratory Bacterial Infections or Superinfections and Colonizations in Patients With Spinal Muscular Atrophy Under NIV
A study testing non invasive ventilation samples, patient samples and parent questionnaire in people with Non Invasive Ventilation and Spinal Muscular Atrophy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Non Invasive Ventilation, Spinal Muscular Atrophy, Respiratory Bacterial Infection
- What is being tested?
- non invasive ventilation samples, patient samples and parent questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2023to 22 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Invasive ventilation on tracheotomy
- No ventilation
- Other treatment than Nusinersen or no treatment
- Parental refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- non invasive ventilation samples, patient samples, parent questionnaire
- Keywords
- non invasive ventilation, Spinal Muscular Atrophy, Respiratory Bacterial Infection
- Medical subject headings
- Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non invasive ventilation samplesOther
machine samples for bacterial culture will be performed
patient samplesOther
Patient samples for sputum culture
parent questionnaireOther
parent questionnaire
| Study group | Role | What they receive |
|---|---|---|
| non invasive ventilation | Experimental | SMA patients with NIV Receives: Other: non invasive ventilation samples; Other: patient samples; Other: parent questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of hospitalization days for respiratory exacerbations with germs identical to protocol samples
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start24 Jan 2023
- Primary completion24 Aug 2024
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Invasive VentilationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712330
- Sponsor's protocol ID
- PI2022_843_0095
- Acronym
- AVNIR
- Status last verified
- May 2025
- First submitted
- 26 Jan 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Respiratory Bacterial Infections or Superinfections and Colonizations in Patients With Spinal Muscular Atrophy Under NIV
- ClinicalTrials.gov ID
- NCT05712330
- Acronym / sponsor ID
- AVNIR / PI2022_843_0095
- Keywords
- non invasive ventilation, Spinal Muscular Atrophy, Respiratory Bacterial Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non invasive ventilation | Experimental | Other: non invasive ventilation samples, Other: patient samples, Other: parent questionnaireSMA patients with NIV |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Invasive ventilation on tracheotomy
- No ventilation
- Other treatment than Nusinersen or no treatment
- Parental refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non invasive ventilation samplesmachine samples for bacterial culture will be performed | Other | non invasive ventilation |
| patient samplesPatient samples for sputum culture | Other | non invasive ventilation |
| parent questionnaireparent questionnaire | Other | non invasive ventilation |
Primary outcome
number of hospitalization days for respiratory exacerbations with germs identical to protocol samples
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non invasive ventilation samples, patient samples and parent questionnaire in people with Non Invasive Ventilation and Spinal Muscular Atrophy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of hospitalization days for respiratory exacerbations with germs identical to protocol samples (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.