Study of Nirsevimabs Impact on RSV Hospitalizations in Infants Under 1 Year Old

What this Trial Is About

This research aims to evaluate the impact of Nirsevimab, a monoclonal antibody used to prevent respiratory syncytial virus RSV infection, in reducing hospitalizations related to RSV in infants under one year of age. Conducted at eight pediatric departments in Tuscany, Italy, the study includes a matched case-control portion investigating how well Nirsevimab prevents RSV-related lower respiratory tract infection hospitalizations during the 2024-2025 RSV epidemic season. Additionally, a descriptive study examines how the immunization campaign with Nirsevimab influences RSV patterns, including patient age, other health conditions, infection severity, and clinical results. Findings will help improve RSV prevention strategies and support public health decisions. The study involves evaluating drug exposure to Nirsevimab among two groups infants under 12 months hospitalized with confirmed bronchiolitis or pneumonia cases and infants under 12 months hospitalized for conditions other than respiratory infections controls. The evaluation period spans November 2024 to March 2025, focusing on the proportion of children immunized with Nirsevimab who are hospitalized for RSV-related lower respiratory tract infections compared to controls. This observational study collects data without administering treatments. Participants are infants younger than 12 months admitted to hospital with either RSV-related lower respiratory tract infections or other conditions. Researchers will review medical records and test results, including RSV PCR on nasopharyngeal swabs, to assess immunization status and clinical outcomes. The study monitors the real-world use and effectiveness of Nirsevimab during the RSV season while analyzing patterns of infection and severity. The total study period covers the RSV epidemic season from November 2024 through March 2025.

Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.