Clinical trial NCT01175252: Trends Over Time (1990-2010) of Diarrhoea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil
Official title: Time Trend Analysis of Diarrhea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil, 1990-2010
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diarrhoea
Gastroenteritis
Keywords: Gastroenteritis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-08-04
Enrollment: 1
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
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.

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™.

Eligibility 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

Primary outcomes:
measure: Occurrence of all cause gastroenteritis related hospital discharges and deaths
timeFrame: 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:
measure: Occurrence of all cause gastroenteritis related hospital discharges and hospital deaths by year, region and age groups
timeFrame: From 1998 to 2010
measure: Occurrence of all cause gastroenteritis related deaths by year, region and age groups
timeFrame: From 1990 to 2009
Other outcomes:
Locations:
city: Belem
country: Brazil
facility: GSK Investigational Site
state: Pará
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.