Dehydration, Gastroenteritis
Conditions
Keywords
rotavirus, gastroenteritis, children, Pediatric, dehydration, vaccine
Brief summary
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
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.
Interventions
None listed
Sponsors
Makassed General Hospital
Rafic Hariri University Hospital
Hotel Dieu de France Hospital
Hammoud Hospital University Medical Center
Hopital Nini
Nabatieh Governmental Hospital
American University of Beirut Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age | 2 years | Incidence of rotavirus gastroenteritis associated hospitalization in children \< 5 years of age was 30.3% by PCR |
Secondary
| Measure | 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 |
Countries
Lebanon
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hospitalized Gastroenteritis Children under 5 years of age hospitalized with gastroenteritis | 1,555 |
| Total | 1,555 |
Baseline characteristics
| Characteristic | Hospitalized Gastroenteritis | — |
|---|---|---|
| Age, Continuous | 22 Months | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Lebanon | 1555 Participants | — |
| Sex: Female, Male Female | 769 Participants | — |
| Sex: Female, Male Male | 786 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,414 |
| other Total, other adverse events | 0 / 1,414 |
| serious Total, serious adverse events | 0 / 1,414 |
Outcome results
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
Time frame: 2 years
Population: Children under 5 years of age hospitalized with gastroenteritis had a 30.3% rate of rotavirus infection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hospitalized Gastroenteritis | Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age | 428 Participants |
Secondary
Determining Seasonal Changes and Year-to-year Changes With Respect to Predominant RV Genotypes
Time frame: 2 years
Secondary
Determining the Age and Seasonal Distribution of RV Associated Hospitalizations in Children < 5 Years of Age
Time frame: 2 years
Secondary
Estimating the Proportion of Diarrheal Hospitalization Due to RV in Children < 5 Years of Age.
Time frame: 2 years
Secondary
Identifying the Most Prevalent RV Genotypes in the Target Population Included in the Surveillance Program
Time frame: 2 years