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Background: Recent evidence demonstrates that rotavirus vaccination is the best strategy for reducing rotavirus gastro-enteritis (RVGE) in young children. Aims: This study describes the epidemiology of RVGE hospitalisation of Sicilian children before universal rotavirus vaccination was introduced into the regional immunisation programme in January 2013. Methods: An observational study was undertaken by analyzing data obtained from the Regional Hospital Discharge database, including hospitalisation from 2003 to 2012 of subjects aged 0–59 months who lived in Sicily. Children discharged with the rotavirus-specific ICD-9-CM code of 008.61 on first or any diagnosis stage were considered to be RVGE cases. Results: From 2003 to 2012, 9317 children (median age 19 months, M/F ratio 1.19) were hospitalised with a diagnosis of RVGE. During the study period, annual rates of hospitalisation were between 2.64 and 4.68 cases/1000 children (mean 3.74 cases). Incidence rates were higher in children aged 6–11 months (8.85/ 1,000 children/year), decreasing significantly with age (P,0.001). RVGE hospitalisation peaked during winter and spring with a statistically significant downward trend throughout summer and autumn. Conclusion: During the study period, the cumulative risk of hospitalisation with RVGE was determined to be about one in 54 Sicilian children in the 1st 5 years of life. Although the present study cannot be considered a proper pharmaco-economic evaluation, the findings suggest that in Sicily the health and economic burden of RVGE hospitalisation strongly supports the introduction of rotavirus vaccination into the regional immunisation programme as a probably cost-saving intervention. [ABSTRACT FROM AUTHOR]