Asthma, Bronchiolitis, Pneumonia
Conditions
Brief summary
This study is an observational, multicenter and prospective study for surveillance of case of hospitalised children acute respiratory distress or lower respiratory tract infections
Detailed description
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
Interventions
None listed
Sponsors
Association Clinique Thérapeutique Infantile du val de Marne
Sanofi
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of children hospitalized for bronchiolitis | 1 year | Assessment of the number of children hospitalized for bronchiolitis in the context of Nirsevimab immunization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of children under 12 months hospitalized for bronchiolitis based on different age groups | 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). |
| Proportion of children under 24 months hospitalized for pneumonia based on different age groups | 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. |
| Proportion of children under 24 months hospitalized for asthma based on different age groups | 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. |
| Evaluate severity case of hospitalized children | 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. |
| Clinical characteristics of hospitalized children | 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). |
| Duration of children's hospitalization in France | 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). |
| Proportion of other viruses associated to bronchiolitis hospitalization | 1 year | Assessment of the proportion of other viruses (isolated or associated with RSV) associated to bronchiolitis hospitalization. |
Countries
France
Contacts
STUDY_DIRECTORLevy Corinne
Association Clinique Thérapeutique Infantile du val de Marne
PRINCIPAL_INVESTIGATORJeziorski Eric
CHU Montpellier, Service Urgence et Post-urgences pédiatrique
Outcome results
None listed