National Observatory of Children Hospitalized for Bronchiolitis

Recruiting

• Conditions: Bronchiolitis

• Registration Number: NCT06112132
• Lead Sponsor: Association Clinique Thérapeutique Infantile du val de Marne

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.

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-15
• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-01
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients hospitalized for bronchiolitis	1 year	Assessment of the number of hospitalized bronchiolitis in the context of routine immunization with Nirsevimab

Secondary Outcome Measures

Name	Time	Method
Proportion of RSV vs non-RSV associated to bronchiolitis hospitalizations	1 year	Assessment of proportion of RSV vs non- RSV associated bronchiolitis hospitalizations
Length of hospital stay of children with bronchiolitis in France according to immunization status with Nirsevimab	1 year	Assesment of the duration of hospitalization for bronchiolitis according to immunization status with Nirsevimab
Proportion of other viruses associated to bronchiolitis hospitalizations.	1 year	Assessment of the proportion of other viruses (isolated or associated with RSV) associated bronchiolitis hospitalizations
Proportion of patients immunized with Nirsevimab among children hospitalized for bronchiolitis	1 year	Description of immunization status with Nirsevimab of hospitalized patients for bronchiolitis overall (RSV+, RSV-) and other viruses (isolated or associated with RSV)
Proportion of demographics and clinical characteristics of patients hospitalized for bronchiolitis overall	1 year	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)
Proportion of demographics, clinical and viral characteristics of patients hospitalized for bronchiolitis requiring ventilation support	1 year	Description of demographics (including immunization status with Nirsevimab), clinical and viral characteristics of patients hospitalized for bronchiolitis requiring ventilation support
Length of hospital stay of children with bronchiolitis overall in France	1 year	Assesment of the duration of hospitalization for bronchiolitis overall (RSV+, RSV-) in France

Trial Locations

Locations (1)

ACTIV; 🇫🇷 Créteil, France