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OVNI: National Observatory of Children Hospitalized for Bronchiolitis

Sponsor
Association Clinique Thérapeutique Infantile du val de Marne (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06112132
Collaborator
(none)
2,500
Enrollment
1
Location
11.5
Anticipated Duration (Months)
216.8
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    National Observatory of Children Hospitalized for Bronchiolitis
    Actual Study Start Date :
    Oct 15, 2023
    Anticipated Primary Completion Date :
    Sep 30, 2024
    Anticipated Study Completion Date :
    Sep 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Proportion of RSV vs non-RSV associated to bronchiolitis hospitalizations [1 year]

      Assessment of proportion of RSV vs non- RSV associated bronchiolitis hospitalizations

    2. 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

    3. 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)

    4. 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)

    5. 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

    6. 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

    7. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 12 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ACTIV Créteil France 94000

    Sponsors and Collaborators

    • Association Clinique Thérapeutique Infantile du val de Marne

    Investigators

    • Study Director: Levy Corinne, Association Clinique Thérapeutique Infantile du val de Marne
    • Principal Investigator: Jeziorski Eric, CHU Montpellier, Service Urgence et Post-urgences pédiatrique

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Association Clinique Thérapeutique Infantile du val de Marne
    ClinicalTrials.gov Identifier:
    NCT06112132
    Other Study ID Numbers:
    • OVNI
    First Posted:
    Nov 1, 2023
    Last Update Posted:
    Nov 1, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bronchiolitis

    Study Results

    No Results Posted as of Nov 1, 2023