跳至主要内容
临床试验/NCT06038071
NCT06038071招募中不适用

Efficacy and Safety of Family Mid-upper Arm Circumference (MUAC) After Recovery From Severe and Moderate Acute Malnutrition

Action Against Hunger USA4 个研究点 分布在 1 个国家目标入组 3,600 人开始时间: 2023年9月25日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather Stobaugh

Senior Research and Learning Specialist

Action Against Hunger USA

研究点 (4)

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