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NCT06112132 Clinical Trial

National Observatory of Children Hospitalized for Bronchiolitis

Bronchiolitis Clinical Trial

— OVNI  

Official title:
National Observatory of Children Hospitalized for Bronchiolitis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06112132
Other study ID # OVNI
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 15, 2023
Est. completion date September 30, 2024

Study information
Verified date October 2023
Source Association Clinique Thérapeutique Infantile du val de Marne
Contact Levy Corinne
Phone 1 48 85 04 04
Email corinne.levy@activ-france.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is an observational, multicenter and prospective study for surveillance of case of hospitalised children for bronchiolitis associated or not to RSV or other viruses (isolated or associated with RSV)

Description:

The aim of this surveillance is to observe and describe the cases hospitalized for bronchiolitis in the 2023/2024 season in the context of routine immunization with Nirsevimab.

Recruitment information / eligibility
Status Recruiting
Enrollment 2500
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Day to 12 Months
Eligibility Inclusion Criteria: - Children under 12 months of age - In one of the 6 study sites - From October 15, 2023 - For acute bronchiolitis defined according to current national and international recommendations - Hospitalized from the pediatric emergency department. Exclusion Criteria: - Refusal to participate by patient relative or legal representative

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France ACTIV Créteil

Sponsors (2)
Lead Sponsor Collaborator
Association Clinique Thérapeutique Infantile du val de Marne Sanofi

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients hospitalized for bronchiolitis Assessment of the number of hospitalized bronchiolitis in the context of routine immunization with Nirsevimab 1 year
Secondary Proportion of RSV vs non-RSV associated to bronchiolitis hospitalizations Assessment of proportion of RSV vs non- RSV associated bronchiolitis hospitalizations 1 year
Secondary Proportion of other viruses associated to bronchiolitis hospitalizations. Assessment of the proportion of other viruses (isolated or associated with RSV) associated bronchiolitis hospitalizations 1 year
Secondary Proportion of patients immunized with Nirsevimab among children hospitalized for bronchiolitis Description of immunization status with Nirsevimab of hospitalized patients for bronchiolitis overall (RSV+, RSV-) and other viruses (isolated or associated with RSV) 1 year
Secondary Proportion of demographics and clinical characteristics of patients hospitalized for bronchiolitis overall Description of demographics (including immunization status with Nirsevimab) and clinical characteristics of patients hospitalized for bronchiolitis overall ( RSV+, RSV-) and other viruses (isolated or associated with RSV) 1 year
Secondary Proportion of demographics, clinical and viral characteristics of patients hospitalized for bronchiolitis requiring ventilation support Description of demographics (including immunization status with Nirsevimab), clinical and viral characteristics of patients hospitalized for bronchiolitis requiring ventilation support 1 year
Secondary Length of hospital stay of children with bronchiolitis overall in France Assesment of the duration of hospitalization for bronchiolitis overall (RSV+, RSV-) in France 1 year
Secondary Length of hospital stay of children with bronchiolitis in France according to immunization status with Nirsevimab Assesment of the duration of hospitalization for bronchiolitis according to immunization status with Nirsevimab 1 year
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