National Observatory of Children Hospitalized for Bronchiolitis

Association Clinique Thérapeutique Infantile du val de Marne1 site in 1 country2,500 target enrollmentOctober 15, 2023

ConditionsBronchiolitis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Bronchiolitis
Sponsor: Association Clinique Thérapeutique Infantile du val de Marne
Enrollment: 2500
Locations: 1
Primary Endpoint: Number of patients hospitalized for bronchiolitis
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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)

Detailed 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.

Registry

clinicaltrials.gov

Start Date

October 15, 2023

End Date

September 30, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of patients hospitalized for bronchiolitis

Time Frame: 1 year

Assessment of the number of hospitalized bronchiolitis in the context of routine immunization with Nirsevimab

Secondary Outcomes

Proportion of RSV vs non-RSV associated to bronchiolitis hospitalizations(1 year)
Length of hospital stay of children with bronchiolitis in France according to immunization status with Nirsevimab(1 year)
Proportion of other viruses associated to bronchiolitis hospitalizations.(1 year)
Proportion of patients immunized with Nirsevimab among children hospitalized for bronchiolitis(1 year)
Proportion of demographics and clinical characteristics of patients hospitalized for bronchiolitis overall(1 year)
Proportion of demographics, clinical and viral characteristics of patients hospitalized for bronchiolitis requiring ventilation support(1 year)
Length of hospital stay of children with bronchiolitis overall in France(1 year)