National Observatory of Children Hospitalized With Bronchiolitis

NCT07485907 | Not Yet Recruiting

• 1 other identifier: OVNI3
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Difference of effectiveness during the 2 seasons (2024/2025 vs 2025/2026)

  2 years

• Hospitalization Proportions according to Nirsevimab and RSV Status, based on different age Groups

  6 months

• Proportion of hospitalizations for bronchiolitis associated with other viruses (isolated or associated with RSV)

  6 months

Study Arms (1)

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

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children hospilalized for bronchiolitis

You may qualify if:

• 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

You may not qualify if:

• Refusal to participate by the legal representative
• Maternal immunization with abrysvo after September 1st 2025

Sponsors & Collaborators

• Association Clinique Thérapeutique Infantile du val de Marne: lead
• GPIP : Groupe de Pathologies Infectieuses Pédiatriques, membre de la Société Française de Pédiatrie: collaborator

Study Sites (1)

ACTIV

Créteil, 94000, France

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Corinne Levy

  Association Clinique Thérapeutique Infantile du val de Marne

  STUDY DIRECTOR

• Eric Jeziorski

  CHU Montpellier, Service Urgence et Post-urgences pédiatrique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corinne Levy

CONTACT

1 48 85 04 04; corinne.levy@activ-france.fr

Stéphane Béchet

CONTACT

1 48 85 96 68; stephane.bechet@activ-france.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 20, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

FR (1)