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| Name | Class |
|---|---|
| Makassed General Hospital | OTHER |
| Rafic Hariri University Hospital | OTHER |
| Hotel Dieu de France Hospital | OTHER |
| Hammoud Hospital University Medical Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospitalized Gastroenteritis | Children under 5 years of age hospitalized with gastroenteritis |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Children under 5 years of age admitted because of gastroenteritis to 6 major hospitals in Lebanon
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut | Beirut | Lebanon | ||||
| Makassed General Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hospitalized Gastroenteritis | Children under 5 years of age hospitalized with gastroenteritis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Children hospitalized with gastroenteritis
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| ID | Title | Description |
|---|---|---|
| BG000 | Hospitalized Gastroenteritis | Children under 5 years of age hospitalized with gastroenteritis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Children under 5 years of age hospitalized with gastroenteritis had a 30.3% rate of rotavirus infection | Posted | Count of Participants | Participants | 2 years |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hospitalized Gastroenteritis | Children under 5 years of age hospitalized with gastroenteritis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ghassan Dbaibo | American University of Beirut | 961-1-350000 | 4819 | gdbaibo@aub.edu.lb |
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| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
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| OTHER_GOV |
| Hopital Nini | OTHER |
| Nabatieh Governmental Hospital | OTHER |
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Stool samples with rotavirus RNA
| 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 |
| Beirut |
| Lebanon |
| Rafik Hariri University Hospital | Beirut | Lebanon |
| Nini Hospital | Tripoli | Lebanon |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Identifying the Most Prevalent RV Genotypes in the Target Population Included in the Surveillance Program | Not Posted | 2 years | Participants |
| Secondary | Estimating the Proportion of Diarrheal Hospitalization Due to RV in Children < 5 Years of Age. | Not Posted | 2 years | Participants |
| Secondary | Determining the Age and Seasonal Distribution of RV Associated Hospitalizations in Children < 5 Years of Age | Not Posted | 2 years | Participants |
| Secondary | Determining Seasonal Changes and Year-to-year Changes With Respect to Predominant RV Genotypes | Not Posted | 2 years | Participants |
| 0 |
| 1,414 |
| 0 |
| 1,414 |
| 0 |
| 1,414 |
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| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |