NCT03027505已完成不适用
Effectiveness of an Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Passore Province (Northern Region), Burkina Faso
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,958
- 试验地点
- 1
- 主要终点
- Recovery rate
研究概览
简要总结
MUAC only is a pilot trial external control carried out between January 2017 and December 2017 in the Yako district (northern region), Burkina Faso.
The objective of this study is to evaluate an integrated protocol for acute malnourished children without medical complication. The hypotheses of the integrated protocol include :
- A global treatment of acute malnutrition (moderate and severe) with a single treatment (RUTF) would improve the functioning of the program through early identification of acutely malnourished children, while achieving a better coverage and using a single supply chain.
- A gradual reduction of RUTF dosage according to a child's MUAC status could significantly increase the number of children on treatment without increasing overall RUTF quantity while maintaining similar recovery rates.
详细描述
Objectives :
Main objective :
To ensure the recovery rate of the integrated protocol for treatment of acute malnutrition is significantly greater than 75% (reference value of the national program in BF).
Secondary objectives :
- To ensure the mortality rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 3% (reference value of the national BF program).
- To ensure the default rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 15% (reference value of the national BF program).
- To ensure the non-response rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 8%.
- To ensure the hospitalization rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 15%.
- To ensure the coverage rate of the program increases by 30% after the year the integrated protocol was introduced (specific protocol annexed).
- To estimate the relapse rate of the integrated protocol for treatment of acute malnutrition.
- To compare RUTF rations per child of the integrated protocol compared to the national protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Being between 6 and 59 months old
- •New admission
- •Acute malnutrition defined as follows:
- •MUAC<125mm
- •MUAC> 125mm AND WHZ (Z-score) <-3 (WHO standard)
- •Resident in the study area (Yako district)
- •Signed informed consent of the mother or the child's guardian
排除标准
- •Children allergic to milk, peanuts and / or RUTF
研究组 & 干预措施
MUAC<125mm
Experimental
no medical complication
干预措施: Ready to Use Therapeutic Food (RUTF) (Drug)
结局指标
主要结局
Recovery rate
时间窗: Between 4 and 12 weeks
The recovery is defined as below : * Minimum of 4 weeks of participation in the program * MUAC\> = 125 mm on 2 consecutive visits * No edema for minimum 2 weeks * Good Clinical Health
次要结局
- Hospitalization rate(Between inclusion and week 12)
- Mortality rate(Between inclusion and week 12)
- Non-respondent rate(12 weeks after inclusion)
- Relapse rate(up to 3 months)
- RUTF rations(Between inclusion and week 12)
- Default rate(Between 3 and 12 weeks)
研究者
研究点 (1)
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