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