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Completed

NCT Number: NCT06112132

National Observatory of Children Hospitalized for Acute Respiratory Distress or Lower Respiratory Tract Infections

This study is an observational, multicenter and prospective study for surveillance of case of hospitalised children acute respiratory distress or lower respiratory tract infections

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Key information

Conditions

Bronchiolitis Asthma Bronchial Diseases Bronchitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Pneumonia Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 day–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

ACTIV

Créteil, 94000, France

About this study

The aim of this surveillance is to observe and describe cases of children hospitalized for bronchiolitis or pneumonia or asthma in the context of Nirsevimab immunization and according to RSV status

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children under 12 months of age for bronchiolitis or under 24 months of age for pneumonia or under 24 months of age for asthma
  • Hospitalized in one of the 12 study sites
  • From October 15, 2023
  • For acute bronchiolitis or pneumonia or asthma defined according to current national and international recommendations
  • Hospitalized from the pediatric emergency department.

Exclusion criteria

  • Refusal to participate by patient relative or legal representative

Treatment and study plan

Primary outcomes

  1. Number of children hospitalized for bronchiolitis

    Time frame: 1 year

    Assessment of the number of children hospitalized for bronchiolitis in the context of Nirsevimab immunization.

Secondary outcomes

  1. Proportion of children under 12 months hospitalized for bronchiolitis based on different age groups

    Time frame: 1 year

    Assessment of population of children under 12 months hospitalized for bronchiolitis according to their Nirsevimab and RSV status, based on different age groups (under 3 months, 3-6 months, 6-12 months).

  2. Proportion of children under 24 months hospitalized for pneumonia based on different age groups

    Time frame: 1 year

    Assessment of population of children under 24 months hospitalized for pneumonia, according to their Nirsevimab (first or second-year's immunization) and RSV status based on different age groups.

  3. Proportion of children under 24 months hospitalized for asthma based on different age groups

    Time frame: 1 year

    Assessment of population of children under 24 months hospitalized for asthma according to their Nirsevimab (first or second-year's immunization) and RSV status, based on different age groups.

  4. Evaluate severity case of hospitalized children

    Time frame: 1 year

    Assessment of severity case of bronchiolitis or pneumonia or asthma according to RSV and Nirsevimab immunization status (first or second-year's immunization) and according to age groups.

  5. Clinical characteristics of hospitalized children

    Time frame: 1 year

    Assesment of children medical care hospitalised for bronchiolitis or pneumonia or asthma (use of ventilatory support, associated treatment,...) in France (entire population) according to RSV and Nirsevimab immunization status (first or second-year's immunization).

  6. Duration of children's hospitalization in France

    Time frame: 1 year

    Assesment of the duration of children's hospitalization for bronchiolitis or pneumonia or asthma in France, for the entire population and according to RSV ans Nirsevimab immunization status (first or second-year's immunization).

  7. Proportion of other viruses associated to bronchiolitis hospitalization

    Time frame: 1 year

    Assessment of the proportion of other viruses (isolated or associated with RSV) associated to bronchiolitis hospitalization.

Sponsors and collaborators

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Other

Collaborators

  • Sanofi

Registry information

Acronym: OVNI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2023
Registry last updated
Mar 19, 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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