National Observatory of Children Hospitalized for Acute Respiratory Distress or Lower Respiratory Tract Infections (OVNI)

March 17, 2026 updated by: Association Clinique Thérapeutique Infantile du val de Marne
This study is an observational, multicenter and prospective study for surveillance of case of hospitalised children acute respiratory distress or lower respiratory tract infections

Study Overview

Status

Completed

Conditions

Detailed Description

The aim of this surveillance is to observe and describe cases of children hospitalized for bronchiolitis or pneumonia or asthma in the context of Nirsevimab immunization and according to RSV status

Study Type

Observational

Enrollment (Actual)

1827

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94000
        • ACTIV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children hospilalized for bronchiolitis or pneumonia or asthma

Description

Inclusion Criteria:

  • Children under 12 months of age for bronchiolitis or under 24 months of age for pneumonia or under 24 months of age for asthma
  • Hospitalized in one of the 12 study sites
  • From October 15, 2023
  • For acute bronchiolitis or pneumonia or asthma 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Children hospitalized for pneumonia
All children, under 24 months of age, hospitalized for pneumonia
Children hospitalized for asthma
All children, under 24 months of age, hospitalized for asthma
Children hospitalized for bronchiolitis
All children, under 12 months of age, hospitalized for bronchiolitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of children hospitalized for bronchiolitis
Time Frame: 1 year
Assessment of the number of children hospitalized for bronchiolitis in the context of Nirsevimab immunization.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of children under 12 months hospitalized for bronchiolitis based on different age groups
Time Frame: 1 year
Assessment of population of children under 12 months hospitalized for bronchiolitis according to their Nirsevimab and RSV status, based on different age groups (under 3 months, 3-6 months, 6-12 months).
1 year
Proportion of children under 24 months hospitalized for pneumonia based on different age groups
Time Frame: 1 year
Assessment of population of children under 24 months hospitalized for pneumonia, according to their Nirsevimab (first or second-year's immunization) and RSV status based on different age groups.
1 year
Proportion of children under 24 months hospitalized for asthma based on different age groups
Time Frame: 1 year
Assessment of population of children under 24 months hospitalized for asthma according to their Nirsevimab (first or second-year's immunization) and RSV status, based on different age groups.
1 year
Evaluate severity case of hospitalized children
Time Frame: 1 year
Assessment of severity case of bronchiolitis or pneumonia or asthma according to RSV and Nirsevimab immunization status (first or second-year's immunization) and according to age groups.
1 year
Clinical characteristics of hospitalized children
Time Frame: 1 year
Assesment of children medical care hospitalised for bronchiolitis or pneumonia or asthma (use of ventilatory support, associated treatment,...) in France (entire population) according to RSV and Nirsevimab immunization status (first or second-year's immunization).
1 year
Duration of children's hospitalization in France
Time Frame: 1 year
Assesment of the duration of children's hospitalization for bronchiolitis or pneumonia or asthma in France, for the entire population and according to RSV ans Nirsevimab immunization status (first or second-year's immunization).
1 year
Proportion of other viruses associated to bronchiolitis hospitalization
Time Frame: 1 year
Assessment of the proportion of other viruses (isolated or associated with RSV) associated to bronchiolitis hospitalization.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Collaborators

Sanofi

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2023

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVNI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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