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

NCT01175252 | Completed

• 1 other identifier: 112368
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhoea; Gastroenteritis

Keywords

Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• Occurrence of all cause gastroenteritis related hospital discharges and deaths

  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 (2)

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

  From 1998 to 2010

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

  From 1990 to 2009

Study Arms (1)

Gastroenteritis Cohort

All children suffering with gastroenteritis

Other: Database analysis

Interventions

Database analysis OTHER

Review and collect data from database

Gastroenteritis Cohort

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Belém, Pará, 66 090 000, Brazil

Location

Related Publications (3)

• Lanzieri TM et al. The impact of rotavirus vaccination on gastroenteritis hospitalizations among children <5 years in Brazil. Abstract presented at the 6th World Congress of World Society for Pediatric Infectious Diseases (WSPID). Buenos Aires, Argentina, 18-22 November 2009.

  BACKGROUND

• Lanzieri TM, Costa I, Shafi FA, Cunha MH, Ortega-Barria E, Linhares AC, Colindres RE. Trends in hospitalizations from all-cause gastroenteritis in children younger than 5 years of age in Brazil before and after human rotavirus vaccine introduction, 1998-2007. Pediatr Infect Dis J. 2010 Jul;29(7):673-5. doi: 10.1097/INF.0b013e3181da8f23.

  PMID: 20300045 BACKGROUND

• Lanzieri TM et al. Impact of rotavirus vaccination on childhood diarrheal deaths in Brazil. Abstract presented at the 9th International Rotavirus Symposium (IRS). Johannesburg, South Africa, 2-3 August 2010.

  BACKGROUND

MeSH Terms

Conditions

Diarrhea; Gastroenteritis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 4, 2010
• Study Start: December 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 12, 2012

Record last verified: 2012-11

Locations

BR (1)