BronchiolitisOVNINCT06112132
National Observatory of Children Hospitalized for Acute Respiratory Distress or Lower Respiratory Tract Infections
An observational study of Bronchiolitis and Pneumonia, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
Trial summary
This study is an observational, multicenter and prospective study for surveillance of case of hospitalised children acute respiratory distress or lower respiratory tract infections Read more about this study
- Who is it for?
- Ages 1 day to 24 months
- Conditions the study is for
- Bronchiolitis, Pneumonia, Asthma
- How many people
- 1,827 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2023to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: children hospilalized for bronchiolitis or pneumonia or asthma
Who may be able to join
- 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.
Who cannot join
- Refusal to participate by patient relative or legal representative
Trial locations and contacts
1 site in 1 country.
About this study
This study is an observational, multicenter and prospective study for surveillance of case of hospitalised children acute respiratory distress or lower respiratory tract infections
Read the 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
- Conditions
- Bronchiolitis, Pneumonia, Asthma
- Medical subject headings
- Bronchiolitis, Pneumonia, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of children hospitalized for bronchiolitis
Assessment of the number of children hospitalized for bronchiolitis in the context of Nirsevimab immunization.
Measured: 1 year
Secondary outcomes (7)
Proportion of children under 12 months hospitalized for bronchiolitis based on different age groups
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).
Measured: 1 year
Proportion of children under 24 months hospitalized for pneumonia based on different age groups
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.
Measured: 1 year
Proportion of children under 24 months hospitalized for asthma based on different age groups
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.
Measured: 1 year
Evaluate severity case of hospitalized children
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.
Measured: 1 year
Clinical characteristics of hospitalized children
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).
Measured: 1 year
Duration of children's hospitalization in France
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).
Measured: 1 year
Proportion of other viruses associated to bronchiolitis hospitalization
Assessment of the proportion of other viruses (isolated or associated with RSV) associated to bronchiolitis hospitalization.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start27 Oct 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,827 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Levy Corinne, Study director, Association Clinique Thérapeutique Infantile du val de MarneJeziorski Eric, Principal investigator, CHU Montpellier, Service Urgence et Post-urgences pédiatrique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112132
- Sponsor's protocol ID
- OVNI
- Acronym
- OVNI
- Status last verified
- Mar 2026
- First submitted
- 27 Oct 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jeziorski E, Ouziel A, Cotillon M, Bridonneau C, Bizot E, Basse C, Portefaix A, Dubos F, Bechet S, Domitien L, Jaillet C, Abrudan S, Kramer R, Gajdos V, Launay E, Basmaci R, Gillet Y, Cohen R, Levy C. Impact of Nirsevimab on Respiratory Syncytial Virus Bronchiolitis in Hospitalized Infants: A Real-World Study. Pediatr Infect Dis J. 2025 Apr 1;44(4):e124-e126. doi: 10.1097/INF.0000000000004630. Epub 2024 Nov 26.
PubMed 39589139
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Observatory of Children Hospitalized for Acute Respiratory Distress or Lower Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT06112132
- Acronym / sponsor ID
- OVNI / OVNI
- Conditions
- Bronchiolitis, Pneumonia, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,827 participants (actual)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an observational, multicenter and prospective study for surveillance of case of hospitalised children acute respiratory distress or lower respiratory tract infections
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children hospilalized for bronchiolitis or pneumonia or asthma
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Refusal to participate by patient relative or legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Proportion of children under 12 months hospitalized for bronchiolitis based on different age groups
Time frame: 1 year
Proportion of children under 24 months hospitalized for pneumonia based on different age groups
Time frame: 1 year
Proportion of children under 24 months hospitalized for asthma based on different age groups
Time frame: 1 year
Evaluate severity case of hospitalized children
Time frame: 1 year
Clinical characteristics of hospitalized children
Time frame: 1 year
Duration of children's hospitalization in France
Time frame: 1 year
Proportion of other viruses associated to bronchiolitis hospitalization
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Results publication: PubMed 39589139Jeziorski E, Ouziel A, Cotillon M, Bridonneau C, Bizot E, Basse C, Portefaix A, Dubos F, Bechet S, Domitien L, Jaillet C, Abrudan S, Kramer R, Gajdos V, Launay E, Basmaci R, Gillet Y, Cohen R, Levy C. Impact of Nirsevimab on Respiratory Syncytial Virus Bronchiolitis in Hospitalized Infants: A Real-World Study. Pediatr Infect Dis J. 2025 Apr 1;44(4):e124-e126. doi: 10.1097/INF.0000000000004630. Epub 2024 Nov 26.
- Impact of Nirsevimab on Respiratory Syncytial Virus Bronchiolitis in Hospitalized Infants: A Real-World StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Levy Corinne study director
Association Clinique Thérapeutique Infantile du val de Marne
Jeziorski Eric principal investigator
CHU Montpellier, Service Urgence et Post-urgences pédiatrique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis and Pneumonia, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of children hospitalized for bronchiolitis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06112132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.