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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,555
- 试验地点
- 4
- 主要终点
- Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 5 years
- •Gastroenteritis as admitting diagnosis
- •Informed consent
- •Parents willing and able to cooperate
排除标准
- •Age > 5 years
- •Onset of gastroenteritis beyond 12 hours of admission
结局指标
主要结局
Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age
时间窗: 2 years
Incidence of rotavirus gastroenteritis associated hospitalization in children \< 5 years of age was 30.3% by PCR
次要结局
- Estimating the Proportion of Diarrheal Hospitalization Due to RV in Children < 5 Years of Age.(2 years)
- Identifying the Most Prevalent RV Genotypes in the Target Population Included in the Surveillance Program(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)
研究者
Dr. Ghassan Dbaibo
Pediatrician Doctor
American University of Beirut Medical Center