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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Association Clinique Thérapeutique Infantile du val de Marne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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