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NCT Number: NCT07485907

National Observatory of Children Hospitalized With Bronchiolitis

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

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Key information

Conditions

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

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluate the nirsevimab effectiveness for RSV Bronchiolitis hospitalized vs Non-RSV Bronchiolitis in 2025/2026.

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Corinne Levy

CONTACT

[email protected]

1 48 85 04 04 ext. +33

Stéphane Béchet

CONTACT

[email protected]

1 48 85 96 68 ext. +33

Sponsors and collaborators

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Other

Collaborators

  • GPIP : Groupe de Pathologies Infectieuses Pédiatriques, membre de la Société Française de Pédiatrie

Registry information

Acronym: OVNI3

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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