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
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
Refusal to participate by the legal representative
Maternal immunization with abrysvo after September 1st 2025
children hospilalized for bronchiolitis
Case-only
Retrospective
Not listed
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.
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.
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.
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.
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Association Clinique Thérapeutique Infantile du val de Marne
Lead sponsor
GPIP : Groupe de Pathologies Infectieuses Pédiatriques, membre de la Société Française de Pédiatrie
Collaborator
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