Cement flooRs AnD chiLd hEalth (CRADLE): a Randomized Trial in Rural Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Child prevalence of any soil-transmitted helminth infection
研究概览
简要总结
This randomized trial in rural Bangladesh will measure whether installing concrete floors in households with soil floors reduces child enteric infection. The trial will randomize eligible households to receive concrete household floors or to no intervention and measure effects on child soil-transmitted helminth infection, diarrhea, and other enteric infections. The study will collect longitudinal follow-up measurements at birth and when children are ages 3, 6, 12, 18, and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residence in Chauhali upazila or adjacent upazilas in Sirajganj or Tangail districts in Bangladesh
- •No plan to relocate in the next 2-3 years
- •Reside in home with floors made entirely of soil
- •Pregnant woman 13-30 weeks gestation resides in the home at the time of enrollment
排除标准
- •Home is not strictly residential (e.g., includes a business)
- •Household with walls made of mud/soil
- •Household floor size > 500 square feet
研究组 & 干预措施
Concrete household floor
干预措施: Concrete household floor (Other)
Non-intervention
结局指标
主要结局
Child prevalence of any soil-transmitted helminth infection
时间窗: Up to 24 months
Prevalence of Ascaris lumbricoides, Necator americanus, or Trichuris trichiura infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up
次要结局
- Child Ascaris lumbricoides infection prevalence(Up to 24 months)
- Child Necator americanus infection prevalence(Up to 24 months)
- Child Trichuris trichiura infection prevalence(Up to 24 months)
- Child diarrhea prevalence(Up to 24 months)
- Ascaris lumbricoides prevalence in household floor samples(Up to 24 months)
- Necator americanus prevalence in household floor samples(Up to 24 months)
- Trichuris trichiura prevalence in household floor samples(Up to 24 months)
- Any soil-transmitted helminth prevalence in household floor samples(Up to 24 months)
- Culturable E. coli abundance in household floor samples(Up to 24 months)
- Culturable E. coli abundance in child hand rinse samples(Up to 24 months)
- Culturable cefotaxime-resistant E. coli prevalence in household floor samples(Up to 24 months)
研究者
Jade Benjamin-Chung
Assistant Professor of Epidemiology & Population Health
Stanford University