Simplified Treatment of Children With Low WAZ in Mali. A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
- 试验地点
- 11
- 主要终点
- weight-for-age z-score (WAZ)
研究概览
简要总结
Admissions criteria which treat children with only low mid-upper arm circumference (MUAC) or children with low weight-for-height z-score (WHZ) are not aligned with the evidence on which children are at risk of mortality. An analysis of community-based cohort data from Senegal found that a combination of weight-for-age z-score (WAZ) and MUAC criteria identified all children at risk of near-term death associated with severe anthropometric deficits. This finding has led to the suggestion that WAZ<-3 could be added as an independent admissions criterion for therapeutic feeding programs currently admitting children with MUAC<125 mm. However, there is little evidence to inform the debate about whether children with MUAC ≥125 mm and WAZ<-3 would benefit from treatment and, if so, what treatment protocol should be used.
This study will address whether children with WAZ <-3 but MUAC ≥125 mm benefit from therapeutic feeding and whether a simplified protocol is at least as effective as the more complicated weight-based standard protocol for this population.
The study will be a prospective, multi-center, individually randomized controlled trial (RCT). Children aged 6-59 months presenting with MUAC ≥125 mm and WAZ<-3 will be randomized to one of three study arms.
The primary objective of this study is to assess whether therapeutic feeding with a simplified protocol (1 sachet RUTF/day) results in superior nutritional outcomes compared to no therapeutic feeding AND non-inferior nutritional outcomes compared to the WHZ and weight based dosing regimen currently used in CMAM treatment 2 months after diagnosis among children aged 6-59 months with MUAC ≥125 mm and WAZ<-3 .
The primary outcome is the mean WAZ of children. Secondary outcomes include a) proportion of children with WAZ <-3, b) mean MUAC of children, c) proportion of children with MUAC < 125 mm, d) mean WHZ, mean HAZ, e) proportion of children with WHZ<-3 or HAZ<-3, f) change in WAZ, MUAC, WHZ, HAZ from enrolment to endpoint g) mean skinfold thickness measure.
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
- Double (Investigator, Outcomes Assessor)
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
- •Age between 6 and 59 months
- •MUAC ≥125 mm
- •Living in the study catchment area
- •Expects to be able to continue follow-up visits for next 6 months
排除标准
- •nutritional edema
- •Known peanut or milk allergy
- •Severe illnesses requiring inpatient level treatment (according to IMCI guidelines)
- •Medical condition affecting food intake (lip and palate cleft, handicap etc.)
- •Has already taken part in the study
结局指标
主要结局
weight-for-age z-score (WAZ)
时间窗: 2 months after enrolment
the primary outcome is a continuous outcome: a higher WAZ indicates of a positive outcome. To construct WAZ at any point in time, children's age will be calculated based on their age at admission and their weight will be measured at each time point with 0.1kg precision. WAZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.
次要结局
- weight-for-age z-score (WAZ)(6 months after enrolment)
- weight-for-age z-score (WAZ) <-3(both at 2 and 6 months post-enrolment)
- weight-for-height z-score (WHZ)(both at 2 and 6 months post-enrolment)
- Mid-upper-arm circumference (MUAC)(both at 2 and 6 months post-enrolment)
- weight-for-height z-score (WHZ) <-3(both at 2 and 6 months post-enrolment)
- height-for-age z-score (HAZ)(both at 2 and 6 months post-enrolment)
- height-for-age z-score (HAZ) <-3(both at 2 and 6 months post-enrolment)