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

November 8, 2012 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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™.

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pará
      • Belem, Pará, Brazil, 66 090 000
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children <5 years of age being hospitalized due to gastroenteritis between 1998 and 2010 and deceased due to gastroenteritis between 1990 and 2009 in Brazil.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastroenteritis Cohort
All children suffering with gastroenteritis
Other: Database analysis
Review and collect data from database

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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 Outcome Measures

Outcome Measure
Time Frame
Occurrence of all cause gastroenteritis related hospital discharges and hospital deaths by year, region and age groups
Time Frame: From 1998 to 2010
From 1998 to 2010
Occurrence of all cause gastroenteritis related deaths by year, region and age groups
Time Frame: From 1990 to 2009
From 1990 to 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 3, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (Estimate)

August 4, 2010

Study Record Updates

Last Update Posted (Estimate)

November 12, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112368

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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