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Trends Over Time (1990-2010) of Diarrhoea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil

Completed
Conditions
Gastroenteritis
Diarrhoea
Interventions
Other: Database analysis
Registration Number
NCT01175252
Lead Sponsor
GlaxoSmithKline
Brief Summary

This study aims at collecting data to obtain baseline incidence and monitor trends over time in hospitalizations and deaths from all cause gastroenteritis in children \<5 years of age, before and after implementation of Rotarix™ universal mass vaccination in Brazil.

Detailed Description

In this study baseline gastroenteritis related hospital discharges and mortality data from the Ministry of Health databases (DATASUS) will be compared to the current data after introduction of Rotarix™.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1
Inclusion Criteria
  • Gastroenteritis associated hospital discharges and gastroenteritis related deaths occurring in children <5 years of age during the period analyzed and registered in the DATASUS databases will be collected for the study
Exclusion Criteria
  • Not applicable

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Gastroenteritis CohortDatabase analysisAll children suffering with gastroenteritis
Primary Outcome Measures
NameTimeMethod
Occurrence of all cause gastroenteritis related hospital discharges and deathsIn post vaccine introduction period compared to pre-vaccination period (gastroenteritis related hospital discharges from 1998 to 2010, gastroenteritis related deaths from 1990 to 2009)
Secondary Outcome Measures
NameTimeMethod
Occurrence of all cause gastroenteritis related hospital discharges and hospital deaths by year, region and age groupsFrom 1998 to 2010
Occurrence of all cause gastroenteritis related deaths by year, region and age groupsFrom 1990 to 2009

Trial Locations

Locations (1)

GSK Investigational Site

🇧🇷

Belem, Pará, Brazil

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