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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01175252
First received: August 3, 2010
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Diarrhoea
Gastroenteritis
 Other: Database analysis

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Time Trend Analysis of Diarrhea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil, 1990-2010

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of all cause gastroenteritis related hospital discharges and hospital deaths by year, region and age groups [ Time Frame: From 1998 to 2010 ] [ Designated as safety issue: No ]
  • Occurrence of all cause gastroenteritis related deaths by year, region and age groups [ Time Frame: From 1990 to 2009 ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: December 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Gastroenteritis Cohort
All children suffering with gastroenteritis
 Other: Database analysis
Review and collect data from database

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™.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175252

Locations
Brazil
GSK Investigational Site
Belem, Pará, Brazil, 66 090 000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01175252     History of Changes
Other Study ID Numbers: 112368
Study First Received: August 3, 2010
Last Updated: November 8, 2012
Health Authority: Brazil: ANVISA

Keywords provided by GlaxoSmithKline:
Gastroenteritis

Additional relevant MeSH terms:
Diarrhea
Gastroenteritis
Signs and Symptoms, Digestive
 Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013