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临床试验/NCT02994212
NCT02994212已完成不适用

Reduced Frequency of Visits in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety

Epicentre0 个研究点目标入组 115 人开始时间: 2014年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Epicentre
入组人数
115
主要终点
weight loss > 5%

研究概览

简要总结

Community-based management of severe acute malnutrition (SAM) has been shown to be safe and cost-effective, but program coverage remains low. New treatment models that maintain high levels of clinical effectiveness but allow for increased coverage are still needed. A reduced schedule of follow-up, in which children receive clinical follow-up and therapeutic foods on a monthly rather than weekly or biweekly basis, may be one alternative. This study aims to describe the safety and feasibility of a monthly distribution of ready-to-use therapeutic food in the treatment of uncomplicated SAM, in terms of clinical response to treatment and household ready-to-use therapeutic food (RUTF) utilization. This is a non-randomized pilot intervention study in which 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis for 4 weeks to monitor treatment response defined as weight gain, (mid-upper arm circumference) MUAC gain, weight loss > 5%, and the development of edema. Unannounced household spot checks were conducted over 4 weeks to assess household utilization of RUTF and storage practices.

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

入选标准

  • a) being eligible for new admission to treatment of uncomplicated SAM
  • b) being resident within 15 km of the study health center

排除标准

  • previously default from previous SAM treatment (e.g. missed 2 consecutive weekly visits)
  • considered a relapse case (e.g. re-admitted within three months of previous discharge)

结局指标

主要结局

weight loss > 5%

时间窗: 4 weeks

weight gain

时间窗: 4 weeks

grams/kilograms/day gained

mid-upper arm circumference gain (mm/day)

时间窗: 4 weeks

millimeters gained per day

development of edema

时间窗: 4 weeks

次要结局

  • correct utilization of RUTF(4 weeks)

研究者

发起方
Epicentre
申办方类型
Other
责任方
Sponsor

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