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临床试验/NCT02751476
NCT02751476Unknown不适用

Effectiveness of Safe Drinking Water in Community Based Treatment of Severe Acute Malnutrition

Action Contre la Faim0 个研究点目标入组 820 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
820
主要终点
Recovery rate

研究概览

简要总结

This study builds evidence on the importance of using safe drinking water during the nutritional treatment of children affected by Severe Acute Malnutrition (SAM). The following hypotheses will be tested: 1.The addition of safe drinking water to SAM treatment will reduce exposure to pathogens that cause diarrhoeal disease, thereby reducing diarrhoea incidence among enrolled children. 2.Reductions in pathogen exposure and diarrhoeal disease will result in shorter recovery pe-riods for children with SAM. The study will evaluate the effectiveness of safe drinking water in reducing SAM treatment cost and duration and will provide recommendations for improving SAM treatment protocols.

详细描述

A four group randomized control trial (RCT) will be used to evaluate the effectiveness of safe drinking water in SAM treatment protocols. Intervention groups will include: 1) standard SAM treatment (control group); 2) standard SAM treatment + flocculent-disinfectant water treatment (P&G Purifier of Water); 3) standard SAM treatment + chlorine disinfectant ("Aquatabs", a locally available mass market product); and 4) standard SAM treatment + ceramic water filter (locally available mass market product). All intervention groups will receive the standard SAM nutrition treatment and hygiene education. The control group will receive standard Community Managed Acute Malnutrition (CMAM) treatment only and households will use existing water treatment methods to represent the conventional CMAM program and to enable comparison with the other study arms (with improved water provision methods). A RCT was identified because it is a rigorous gold standard methodology design that is feasible given the context, and appropriate for determining whether or not safe drinking water is effective in CMAM programs. Site level randomization will be used and is preferable to individual randomization from a management perspective and because it increases likelihood of fidelity to the planned intervention. Limitations of the proposed design include 1) potential for bias because the study is not blinded and 2) possible contamination of the comparison groups. In order to minimize these risks, efforts will be made to geographically separate the comparison groups to reduce the risk of sharing of water treatment products. Blinding is not possible given the obviously different nature of the three PoU water treatment approaches and the need for a control group.

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
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

入选标准

  • Children in each selected community will be eligible for inclusion in the study if they are
  • between six and 59 months of age,
  • diagnosed as an uncomplicated SAM case
  • enrolled in ACF's CMAMprogram
  • if the child's caretaker gives consent for the child's participation.

排除标准

  • Children will be ineligible for participation if
  • they have a diagnosis of kwashiorkor; OR 2) they require in-patient treatment for SAM
  • their caretakers are unwilling or unable to agree to their participation.
  • Children graduating from in-patient treatment (i.e no remaining medical complications) to the out-patient CMAM program will be eligible for participation.

结局指标

主要结局

Recovery rate

时间窗: 5 months

the total number of cured children / total number of exited children (including cured, deceased, and lost to follow-up)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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