Home and Community Management of Fevers/Malaria and Pneumonia in Children Under-five: a Cluster Randomised Controlled Trial of an Integrated Approach in a Rural District of Burkina Faso
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11,500
- 试验地点
- 1
- 主要终点
- Number of death in children aged 6 to 59 months
研究概览
简要总结
A well-implemented community-based program of early and appropriate treatment of fevers/malaria episodes and pneumonia,will improve child survival as measured by a reduction of the less than five mortality rate.
详细描述
An integrated approach of home and community management of malaria and pneumonia may increase the proportion of children receiving prompt treatment; improve child survival as measured by a reduction of the under five mortality rate. To test this hypothesis, a cluster randomised controlled trial will be performed, involving children less than 5 years of age, in Burkina Faso using a community-based supplying community health workers (CHWs), a core group of mothers (KOLs) with Coartem and cotrimoxazole specially packed in age-specific blisters containing a full course of treatment. The study will be carried out in 111 clusters of a rural district in Burkina Faso where malaria and pneumonia are two major mortality causes in under five mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •living in one of the study cluster (villages)
- •no story of allergy to any of the study drugs
- •history of fever or body temperature >= 38.5°C
排除标准
- •signs of severity/complications like impaired consciousness, convulsions, fast breathing etc
结局指标
主要结局
Number of death in children aged 6 to 59 months
时间窗: 12 months
annual crude mortality rate in children aged 0 to 6 months in the different study arms
次要结局
- - specific mortality preceded by acute febrile illness of children aged 6 to 59 months - severe malaria cases at community level(12 months)
研究者
Sodiomon B. Sirima
Dr
World Health Organization