An observational study in Bronchiolitis, sponsored by Association Clinique Thérapeutique Infantile du val de Marne. Not yet recruiting at 1 site in France. Open to participants aged 1 Day to 12 Months. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Association Clinique Thérapeutique Infantile du val de Marne · Observational
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
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.
289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 79 observational studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →Association Clinique Thérapeutique Infantile du val de Marne is the lead sponsor of 15 studies on the registry; 11 are open to participants now.
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children hospilalized for bronchiolitis
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Exclusion Criteria:
collected data of all children, under 12 months of age, hospitalized for bronchiolitis from the October 15, 2025 to February 15, 2026
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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Mar 2026; primary completion for Sep 2026, 6 months later.
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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Association Clinique Thérapeutique Infantile du val de Marne