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Starting soon Observational

National Observatory of Children Hospitalized With Bronchiolitis

NCT07485907 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-03-15
Last updated
2026-03-20

Condition(s) studied

Bronchiolitis

Study 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

Eligibility

Sex
ALL
Min age
1 Day
Max age
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
ACTIV Créteil France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07485907 on ClinicalTrials.gov ↗ ← All trials in France