Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality in Children Aged 6 to 24 Month Hadjer-Lamis Region - Chad
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5,700
- 试验地点
- 1
- 主要终点
- Incidence of acute severe malnutrition
研究概览
简要总结
The hypothesis for the study is that 12 months of a Ready-To-Use Supplementary Food (RUSF) distributions have a greater impact on children's health than the standard RUSF distributions during the hunger gap period (june to september). We estimated that the 12 month RUSF will decrease the incidence of severe acute malnutrition by 33% compared to an administration only during the hunger gap period (4 month a year).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children between 6 months and 24 months of age
排除标准
- •children who can 't swallow
- •children from parents who does not want to be in the study
研究组 & 干预措施
12 months RUSF
Children between 6 to 24 months received ready-to-used supplementary food every months during the whole year.
干预措施: Ready-to-Used Supplement Food administration (Dietary Supplement)
4 months RUSF
children between 6 to 24 months of one zone received a ready-to-used supplement food during the 4 months of the hunger gap period (june to september)
干预措施: Ready-to-Used Supplement Food administration (Dietary Supplement)
结局指标
主要结局
Incidence of acute severe malnutrition
时间窗: overall study time, 22 months
Incidence of acute severe malnutrition will be assessed for the overall 2 years. Estimation if incidence will include children from their entry in the study to their exit of study (disharge as 24 months, dead of Lost of follow up )
Mortality rate
时间窗: overall study time 22 months
Mortality will be assessed for the overall 2 years. Estimation will include children from their entry in the study to their exit of study (disharge as 24 months, dead of Lost of follow up )
次要结局
- Morbidity(overall study time 22 months)
- Weight for Height gain(22 months)
- Gain of mid-upper-arm circumference (MUAC) gain(22 months)
研究者
France Broillet
Chargé de recherche operationnelle
Médecins Sans Frontières, Switzerland