Bronchiolitis
Conditions
Brief 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
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.
Interventions
None listed
Sponsors
Association Clinique Thérapeutique Infantile du val de Marne
GPIP : Groupe de Pathologies Infectieuses Pédiatriques, membre de la Société Française de Pédiatrie
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 12 Months
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Refusal to participate by the legal representative * Maternal immunization with abrysvo after September 1st 2025
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the nirsevimab effectiveness for RSV Bronchiolitis hospitalized vs Non-RSV Bronchiolitis in 2025/2026. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference of effectiveness during the 2 seasons (2024/2025 vs 2025/2026) | 2 years | 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 | 6 months | 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) | 6 months | 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. |
Countries
France
Contacts
CONTACTCorinne Levy
CONTACTStéphane Béchet
STUDY_DIRECTORCorinne Levy
Association Clinique Thérapeutique Infantile du val de Marne
PRINCIPAL_INVESTIGATOREric Jeziorski
CHU Montpellier, Service Urgence et Post-urgences pédiatrique
Outcome results
None listed