Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This study is an observational, multicenter and prospective study for surveillance of case of hospitalised children acute respiratory distress or lower respiratory tract infections
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children hospitalized for pneumonia | All children, under 24 months of age, hospitalized for pneumonia | ||
| Children hospitalized for asthma | All children, under 24 months of age, hospitalized for asthma | ||
| Children hospitalized for bronchiolitis | All children, under 12 months of age, hospitalized for bronchiolitis |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of children hospitalized for bronchiolitis | Assessment of the number of children hospitalized for bronchiolitis in the context of Nirsevimab immunization. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of children under 12 months hospitalized for bronchiolitis based on different age groups | 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). | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Refusal to participate by patient relative or legal representative
Not provided
Not provided
children hospilalized for bronchiolitis or pneumonia or asthma
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Levy Corinne | Association Clinique Thérapeutique Infantile du val de Marne | Study Director |
| Jeziorski Eric | CHU Montpellier, Service Urgence et Post-urgences pédiatrique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACTIV | Créteil | 94000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39589139 | Result | Jeziorski E, Ouziel A, Cotillon M, Bridonneau C, Bizot E, Basse C, Portefaix A, Dubos F, Bechet S, Domitien L, Jaillet C, Abrudan S, Kramer R, Gajdos V, Launay E, Basmaci R, Gillet Y, Cohen R, Levy C. Impact of Nirsevimab on Respiratory Syncytial Virus Bronchiolitis in Hospitalized Infants: A Real-World Study. Pediatr Infect Dis J. 2025 Apr 1;44(4):e124-e126. doi: 10.1097/INF.0000000000004630. Epub 2024 Nov 26. |
| Label | URL |
|---|---|
| Impact of Nirsevimab on Respiratory Syncytial Virus Bronchiolitis in Hospitalized Infants: A Real-World Study | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D011014 | Pneumonia |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Proportion of children under 24 months hospitalized for pneumonia based on different age groups |
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. |
| 1 year |
| Proportion of children under 24 months hospitalized for asthma based on different age groups | 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. | 1 year |
| Evaluate severity case of hospitalized children | 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. | 1 year |
| Clinical characteristics of hospitalized children | 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). | 1 year |
| Duration of children's hospitalization in France | 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). | 1 year |
| Proportion of other viruses associated to bronchiolitis hospitalization | Assessment of the proportion of other viruses (isolated or associated with RSV) associated to bronchiolitis hospitalization. | 1 year |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |