Study to Estimate the Disease Burden of Acute Rotavirus Gastroenteritis in Children < 5 Years in United Arab Emirates

Study Overview
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Brief Summary
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The purpose of this study is to estimate the disease burden and epidemiology of rotavirus gastroenteritis in children less than 5 years of age, in United Arab Emirates. Acute gastroenteritis cases will be identified from acute gastroenteritis hospitalisation log book and stool samples will be collected from all suspected and confirmed acute gastroenteritis cases.

Official Title
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An Observational, Hospital-based Surveillance to Estimate the Disease Burden of Acute Rotavirus (RV) Gastroenteritis (GE) in Children < 5 Years of Age in United Arab Emirates (UAE).

Conditions
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Rotaviral Gastroenteritis

Intervention / Treatment
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* Procedure: Stool sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A male or female < 5 years of age at the time of admission to the study hospital for acute gastroenteritis. Written informed consent obtained from the parent or guardian of the subject. Exclusion Criteria: The diagnosis for treatment at the study site does not include acute gastroenteritis. The onset of acute gastroenteritis after admission to the hospital i.e. 48 hours after hospital admission.

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute gastroenteritis Group<br>Suspected/confirmed cases of rotavirus gastroenteritis in children < 5 years of age | Procedure: Stool sampling<br>* Stool samples will be collected, tested and genotyped for the presence of rotavirus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of diarrhoeal hospitalisations in children < 5 years of age, which are attributable to rotavirus. |  | Twelve months from study initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age and seasonal distribution of hospitalisations associated with rotavirus in children < 5 years of age. |  | Twelve months from study initiation | 
| Occurrence of intravenous re-hydration treatment and/or other treatments due to rotavirus gastroenteritis. |  | Twelve months from study initiation | 
| Distribution of different strains of rotavirus in children < 5 years of age. |  | Twelve months from study initiation | 
| Occurrence of acute gastroenteritis and rotavirus gastroenteritis among all hospitalisations of children < 5 years of age. |  | Twelve months from study initiation | 
| Occurrence of severe dehydrating rotavirus gastroenteritis based on Vesikari scale among children < 5 years of age. |  | Twelve months from study initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, gastroenteritis, Rotavirus