Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Kolokani Circle, Koulikoro Region, Mali, August-November 2016: Interventional Matched-pair Clustered Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36,717
- 试验地点
- 1
- 主要终点
- Confirmed malaria case
研究概览
简要总结
SMC LNS Mali is a interventional matched-pair clustered cohort carried out between August and November 2017 in 18 health areas in Kolokani Circle, Koulikoro region, Mali.
The objective of this study is to determine whether the association SMC and LNS reduces the number of confirmed malaria cases among children 6-59 months during the monthly SMC distribution sessions.
详细描述
Main objective:
To compare confirmed cases of malaria among children aged 6-59 months between the group receiving SMC combined with LNS (intervention group) and the group receiving only SMC (control group) during the monthly SMC distribution sessions (4 rounds)
Secondary objectives:
To compare among children aged 6-59 months between two groups
- Fever cases
- Acute malnutrition cases (global, moderate and severe)
- Medical referral cases and their reasons
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Being between 6 and 59 months old
- •Resident in the study area
- •Signed informed consent of the mother or the child's guardian
排除标准
- •Children allergic to milk, peanuts, sulfadoxine-pyrimethamine or amodiaquine
研究组 & 干预措施
SMC and LNS (intervention group)
Children included in the 9 health areas of the intervention group receiving both lipid-based nutrient supplement and seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine
干预措施: Lipid-based Nutrient Supplement (LNS) (Dietary Supplement)
SMC and LNS (intervention group)
Children included in the 9 health areas of the intervention group receiving both lipid-based nutrient supplement and seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine
干预措施: Seasonal malaria chemoprevention (Drug)
SMC only (control group)
Children included in the 9 health areas of the control group receiving seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine
干预措施: Seasonal malaria chemoprevention (Drug)
结局指标
主要结局
Confirmed malaria case
时间窗: From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks
Malaria case is confirmed by a positive malaria rapid diagnostic test. This outcome will be defined as the occurrence of at least one confirmed malaria case from the 2nd through the 4th round of SMC distribution.
次要结局
- Fever case(From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks)
- Global acute malnutrition case(From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks)
- Moderate acute malnutrition case(From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks)
- Severe acute malnutrition case(From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks)
- Medical referral case(From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks)