Rotavirus Burden and Genotypes in a Sentinel Hospital Surveillance System in Lebanon

Study Overview
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Brief Summary
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This study aims to determine the contribution of rotavirus infection as a cause of gastroenteritis requiring hospitalization in children younger than 5 years of age. Additionally, a secondary aim will be to determine the genotypes of rotavirus that cause these infections as prevalent in Lebanon.

Detailed Description
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This study will be performed at six large hospitals in Lebanon in the three largest cities Beirut, Tripoli, and Saida. The study will enroll children younger than 5 years of age who are admitted to the hospital because of gastroenteritis. Enrollment will continue for a period of two years at each hospital. Inclusion criteria are age < 5 years, with gastroenteritis as the main reason for admission to the hospital or for a stay in the Emergency Department longer than 12 hours. Exclusion criteria include onset of symptoms beyond 12 hours of admission (health-care associated infection). For all enrolled subjects, data will be collected about severity of illness, outcome, and history of vaccination. Stool samples will be collected for genotyping of rotavirus.

Official Title
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ESTIMATION OF THE DISEASE BURDEN AND PREVALENT GENOTYPES OF ROTAVIRUS (RV) CAUSING GASTROENTERITIS (GE) IN CHILDREN <5 YEARS OF AGE IN LEBANON BASED ON A SENTINEL HOSPITAL-BASED SURVEILLANCE PROGRAM.

Conditions
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Gastroenteritis, Dehydration

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age < 5 years Gastroenteritis as admitting diagnosis Informed consent Parents willing and able to cooperate Exclusion Criteria: Age > 5 years Onset of gastroenteritis beyond 12 hours of 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 |
| --- | --- |
| Hospitalized Gastroenteritis<br>Children under 5 years of age hospitalized with gastroenteritis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age | Incidence of rotavirus gastroenteritis associated hospitalization in children < 5 years of age was 30.3% by PCR | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identifying the Most Prevalent RV Genotypes in the Target Population Included in the Surveillance Program |  | 2 years | 
| Estimating the Proportion of Diarrheal Hospitalization Due to RV in Children < 5 Years of Age. |  | 2 years | 
| Determining the Age and Seasonal Distribution of RV Associated Hospitalizations in Children < 5 Years of Age |  | 2 years | 
| Determining Seasonal Changes and Year-to-year Changes With Respect to Predominant RV Genotypes |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotavirus, gastroenteritis, children, Pediatric, dehydration, vaccine