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OpenTrials
Completed

NCT Number: NCT01175252

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

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.

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Key information

Conditions

Diarrhoea Diarrhea Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Belém, Pará, 66 090 000, Brazil

About this study

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™.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Database analysis

Other

Review and collect data from database

Primary outcomes

  1. Occurrence of all cause gastroenteritis related hospital discharges and deaths

    Time frame: In 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 outcomes

  1. Occurrence of all cause gastroenteritis related hospital discharges and hospital deaths by year, region and age groups

    Time frame: From 1998 to 2010

  2. Occurrence of all cause gastroenteritis related deaths by year, region and age groups

    Time frame: From 1990 to 2009

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Time Trend Analysis of Diarrhea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil, 1990-2010

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 4, 2010
Registry last updated
Nov 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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