J12.1 J20.5 J21.0 B97.4
Conditions
Interventions
Group 1: Infants (<1 year) of any gender with acute RSV infection requiring hospitalization in Germany
Sponsors
Universitätsklinikum Freiburg, Kinder- und Jugendklinik
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: • Study population: Infants of any gender <12 months of age at hospitalization with positive PCR or rapid test evidence for RSV during RSV season 2024/2025 as defined by the RKI o Risk factors sub-cohort: At least one of the following risk factors for severe disease in RSV infection are present - Chronic lung disease (e.g., bronchopulmonary dysplasia, interstitial lung disease, cystic fibrosis, congenital respiratory abnormalities) - Severe cardiac disorders and/or complex congenital heart defects (e.g., aortic arch abnormalities, hypoplastic left heart syndrome, pulmonary atresia, tricuspid atresia, Fallot tetralogy, large artery transposition, partial or total pulmonary vein defect, other heart valve abnormalities) - Neuromuscular disease (e.g., autonomic dysfunction or dysautonomia, autonomic nervous system instability, corpus callosum agenesis or hypoplasia, muscular dystrophy) - Severe congenital or acquired immunodeficiency - Syndromal disease (e.g., trisomy 21) - Smokers in the family • Vaccinated sub-cohort: Evidence of at least one timely active or passive vaccination against RSV prior to disease onset (e.g., palivizumab, nirsevimab, maternal immunization with RSV preF) Unvaccinated sub-cohort: No active or passive vaccination against RSV prior to disease onset
Exclusion criteria
Exclusion criteria: • Patient records where RSV infection was only documented as a secondary diagnosis or incidental finding and is not considered a primary or substantial reason for hospitalization • Patient records with hospitalization outside the defined RSV season 2024/2025 as defined by RKI • Patient records with missing or incomplete clinical data that make clear assessment of inclusion criteria or vaccination status impossible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the impact of currently available immunization strategies on the disease severity of RSV infections in hospitalized children less than 1 year of age as measured by the duration of hospitalization, the proportion of ICU treatment, and the frequency of serious complications based on medical health records | — |
Secondary
| Measure | Time frame |
|---|---|
| • Assess validity of RSV-specific ICD10 code based data by verification with eMHR (random sample of all cases in season 2024/25, RSV test results) • To characterize patient demographic and clinical characteristics (e.g., age, gender, relevant pre-existing conditions, immunization status) • Description of therapies and diagnostics used and clinical course • Analysis of protective factors as well as risk factors associated with a more severe disease course • Comparison of anonymous RSV-related inpatient case numbers and clinical metadata of children in the first year of life in the RSV seasons 2022/23, 2023/2024 vs. RSV season 2024/2025 (data retrieval via the Center for Data Integration (DIZ) or Medical Controlling) | — |
Countries
Germany
Outcome results
None listed