Trends Over Time (1990-2010) of Diarrhoea-related Incidence, Hospitalizations and Deaths in Children of Panama

June 6, 2017 updated by: GlaxoSmithKline

Time Trend Analysis of Diarrhoea-related Incidence, Hospitalizations, and Deaths in Children < 5 Years of Age in Panama by Monitoring Secondary Data Sources From 1990-2010

This study aims at collecting data from secondary sources to obtain baseline incidence and monitor trends over time (1990 - 2010) of reported gastroenteritis cases, gastroenteritis related hospital discharges and gastroenteritis related deaths in children < 5 years of age in Panama before and after implementation of Rotarix™ universal mass vaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Data will be collected from systematic review of the databases of epidemiologic surveillance system, hospital discharges and deaths for all cause gastroenteritis related outcomes.

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

  • Panama
      • Panama, Panama
        • 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 4 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children <5 years of age reported with gastroenteritis, gastroenteritis related hospital discharges and gastroenteritis related deaths in Panama, between 1990 and 2010.

Description

Inclusion Criteria:

  • Diarrhea cases, diarrhea associated hospital discharges, and diarrhea related deaths occurring in children <5 years of age during the period analyzed and registered in the Epidemiologic Surveillance System of the Ministry of Health, in the mortality database of the Contraloría General de la República and in the hospital discharge records of the selected hospitals, 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastroenteritis Group
All children suffering with gastroenteritis
Other: Epidemiologic Surveillance System of the Ministry of Health of Panama
Reviewing the Epidemiologic Surveillance System of the Ministry of Health of Panama
Other: Mortality database of the Contraloria General de la Republica
Reviewing the Mortality database of the Contraloria General de la Republica
Other: Hospital discharge records
Reviewing the hospital discharge records

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of all cause reported gastroenteritis
Time Frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)
In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)
Occurrence of all cause gastroenteritis related hospital discharges
Time Frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (2000-2005)
In post vaccine introduction period (2006-2010) compared to pre-vaccination period (2000-2005)
Occurrence of all cause gastroenteritis related deaths.
Time Frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)
In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of all cause gastroenteritis-related cases by year, age groups and region
Time Frame: From 1990 to 2010
From 1990 to 2010
Occurrence of all cause gastroenteritis related hospital discharge by year, age groups, hospital and setting
Time Frame: From 2000 to 2010
From 2000 to 2010
Occurrence of all cause gastroenteritis related deaths by year, age groups and region
Time Frame: From 1990 to 2010
From 1990 to 2010

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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

January 1, 2009

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

July 15, 2010

First Submitted That Met QC Criteria

July 27, 2010

First Posted (ESTIMATE)

July 28, 2010

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111757

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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