BronchiolitisOVNI3NCT07485907
National Observatory of Children Hospitalized With Bronchiolitis
An observational study of Bronchiolitis, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
Trial summary
OVNI3 is multicenter, non-interventional study based on the analysis of retrospective patient data extracted from medical records and collected as part of routine clinical care following hospitalization for bronchiolitis Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Bronchiolitis
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2026to 15 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 months
- All sexes
- No healthy volunteers
- Child
Study population: children hospilalized for bronchiolitis
Who may be able to join
- Children under 12 months
- Treated at one of the 12 study sites
- From October 15, 2025 to February 15, 2026
- For acute bronchiolitis defined according to current national and international recommendations
- Hospitalized
- and
- RSV testing
- Known nirsevimab immunization status for the ongoing 2025/2026 season
Who cannot join
- Refusal to participate by the legal representative
- Maternal immunization with abrysvo after September 1st 2025
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
ACTIV
Créteil, 94000
Corinne Levy, 148850404 ext. +33, corinne.levy@activ-france.fr
Stéphane Béchet, 1 48 85 96 68 ext. +33, stephane.bechet@activ-france.fr
About this study
OVNI3 is multicenter, non-interventional study based on the analysis of retrospective patient data extracted from medical records and collected as part of routine clinical care following hospitalization for bronchiolitis
Read the detailed description
Patients will be identified at each participating center if a diagnosis of bronchiolitis meeting the study inclusion criteria is documented in the medical record.
As this is a retrospective study based exclusively on previously collected health data (for hospitalization occurring between October 15, 2025, and February 15, 2026), and involving no additional procedures or modification of patient management, inclusion will be performed by the attending clinicians after hospitalization.
Following identification of the medical record, the clinician will send an individual information notice and a non-opposition form to the legal representatives.
Patient data will be collected in the absence of any expressed objection from one of the legal representatives.
- Conditions
- Bronchiolitis
- Medical subject headings
- Bronchiolitis
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 bronchiolitis | collected data of all children, under 12 months of age, hospitalized for bronchiolitis from the October 15, 2025 to February 15, 2026 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the nirsevimab effectiveness for RSV Bronchiolitis hospitalized vs Non-RSV Bronchiolitis in 2025/2026.
This outcome evaluates the effectiveness of nirsevimab in preventing hospitalizations for RSV bronchiolitis among infants under 12 months of age during the 2025/2026 season. Effectiveness is assessed by comparing the number of hospitalizations for RSV bronchiolitis in infants who received nirsevimab versus those who did not.
Measured: 6 months
Secondary outcomes (3)
Difference of effectiveness during the 2 seasons (2024/2025 vs 2025/2026)
This outcome evaluates the difference in nirsevimab effectiveness by comparing the number of hospitalizations for RSV bronchiolitis among infants immunized with nirsevimab during the 2024/2025 and 2025/2026 seasons. The comparison allows assessment of potential changes in effectiveness across the two consecutive RSV seasons.
Measured: 2 years
Hospitalization Proportions according to Nirsevimab and RSV Status, based on different age Groups
This outcome evaluates the proportion of infants under 12 months hospitalized for bronchiolitis according to their Nirsevimab immunization status and RSV infection status. Analyses are stratified by age groups: under 3 months, 3-6 months, and 6-12 months, to assess variations in hospitalization risk and Nirsevimab effectiveness across age categories.
Measured: 6 months
Proportion of hospitalizations for bronchiolitis associated with other viruses (isolated or associated with RSV)
This outcome evaluates the proportion of hospitalizations for bronchiolitis in infants under 12 months that are associated with viruses other than RSV, either as isolated infections or in co-infection with RSV. The analysis aims to describe the burden of non-RSV viral bronchiolitis and its interaction with RSV infections.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Collaborators
- GPIP : Groupe de Pathologies Infectieuses Pédiatriques, membre de la Société Française de Pédiatrie
- Responsible party
- Sponsor
- Investigators
- Corinne Levy, Study director, Association Clinique Thérapeutique Infantile du val de MarneEric Jeziorski, Principal investigator, CHU Montpellier, Service Urgence et Post-urgences pédiatrique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485907
- Sponsor's protocol ID
- OVNI3
- Acronym
- OVNI3
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Observatory of Children Hospitalized With Bronchiolitis
- ClinicalTrials.gov ID
- NCT07485907
- Acronym / sponsor ID
- OVNI3 / OVNI3
- Conditions
- Bronchiolitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Collaborators
- GPIP : Groupe de Pathologies Infectieuses Pédiatriques, membre de la Société Française de Pédiatrie
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 20 Mar 2026 (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.
OVNI3 is multicenter, non-interventional study based on the analysis of retrospective patient data extracted from medical records and collected as part of routine clinical care following hospitalization for bronchiolitis
Detailed description
Patients will be identified at each participating center if a diagnosis of bronchiolitis meeting the study inclusion criteria is documented in the medical record.
As this is a retrospective study based exclusively on previously collected health data (for hospitalization occurring between October 15, 2025, and February 15, 2026), and involving no additional procedures or modification of patient management, inclusion will be performed by the attending clinicians after hospitalization.
Following identification of the medical record, the clinician will send an individual information notice and a non-opposition form to the legal representatives.
Patient data will be collected in the absence of any expressed objection from one of the legal representatives.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children hospitalized for bronchiolitis | – | –collected data of all children, under 12 months of age, hospitalized for bronchiolitis from the October 15, 2025 to February 15, 2026 |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children hospilalized for bronchiolitis
Key inclusion criteria (8 listed)
- Children under 12 months
- Treated at one of the 12 study sites
- From October 15, 2025 to February 15, 2026
- For acute bronchiolitis defined according to current national and international recommendations
- Hospitalized
Key exclusion criteria (2 listed)
- Refusal to participate by the legal representative
- Maternal immunization with abrysvo after September 1st 2025
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
Evaluate the nirsevimab effectiveness for RSV Bronchiolitis hospitalized vs Non-RSV Bronchiolitis in 2025/2026.
Time frame: 6 months
This outcome evaluates the effectiveness of nirsevimab in preventing hospitalizations for RSV bronchiolitis among infants under 12 months of age during the 2025/2026 season. Effectiveness is assessed by comparing the number of hospitalizations for RSV bronchiolitis in infants who received nirsevimab versus those who did not.
3 secondary outcomes
Difference of effectiveness during the 2 seasons (2024/2025 vs 2025/2026)
Time frame: 2 years
Hospitalization Proportions according to Nirsevimab and RSV Status, based on different age Groups
Time frame: 6 months
Proportion of hospitalizations for bronchiolitis associated with other viruses (isolated or associated with RSV)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Corinne Levy study director
Association Clinique Thérapeutique Infantile du val de Marne
Eric Jeziorski 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, 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 8 inclusion and 2 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: opening soon, as of the sponsor's last update on 20 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corinne Levy (1 48 85 04 04 ext. +33, corinne.levy@activ-france.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the nirsevimab effectiveness for RSV Bronchiolitis hospitalized vs Non-RSV Bronchiolitis in 2025/2026. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2026.