Efficacy and Safety of Family Mid-upper Arm Circumference (MUAC) After Recovery From Severe and Moderate Acute Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,600
- 试验地点
- 4
- 主要终点
- number of episodes of relapse to acute malnutrition identified
研究概览
简要总结
Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. For the Family MUAC follow-up study, children who recover from these two parallel clinical trials will be enrolled in trial to test the effectiveness of MUAC screening at home by the child's caregivers as a self-referral strategy, compared to a scheduled health facility-led strategy and the standard of care of community-based follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •children 6-59 months of old who recovered from SAM or MAM following treatment in either the MODAM-SAM or MODAM-MAM trials
排除标准
- •caregiver not planning on remaining in the local area for the subsequent 6 months
结局指标
主要结局
number of episodes of relapse to acute malnutrition identified
时间窗: 6 months
次要结局
- mid-upper arm circumference (MUAC) at time relapse to acute malnutrition identified(6 months)
- recovery rates following treatment of relapse to acute malnutrition(6 months)
- hospitalization(6 months)
- number of episodes of relapse to edematous malnutrition / kwashiorkor identified(6 months)
- loss to follow-up(6 months)
- weight-for-height Z-score (WHZ) at time relapse to acute malnutrition identified(6 months)
- mortality(6 months)
研究者
Heather Stobaugh
Senior Research and Learning Specialist
Action Against Hunger USA
