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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05712330
Other study ID # PI2022_843_0095
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 24, 2023
Est. completion date September 2024

Study information

Verified date January 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Arnaud BECOURT, MD
Phone 03.22.08.83.71
Email becourt.arnaud@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 8
Est. completion date September 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Years
Eligibility 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

Study Design


Intervention

Other:
non invasive ventilation samples
machine samples for bacterial culture will be performed
patient samples
Patient samples for sputum culture
parent questionnaire
parent questionnaire

Locations

Country Name City State
France Centre Hospitalier Universitaire d'Amiens Amiens Picardie

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of hospitalization days for respiratory exacerbations with germs identical to protocol samples one year
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