To Evaluate the Impact of Three Feeding Regimens on the Recovery of Children From Uncomplicated Severe Acute Malnutrition (SAM) in India and to Use the Evidence to Inform National Policy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 911
- 试验地点
- 6
- 主要终点
- Recovery by 16 weeks after enrollment (defined as achieving weight for height greater than or equal to -2 SD and absence of oedema of both feet)
研究概览
简要总结
This project aims to assess the efficacy of three options under consideration in India for home management of Severe Acute Malnutrition (SAM). The investigators propose to conduct a multi-center randomized controlled trial to determine the efficacy of two community-supported home-based regimes using centrally or locally produced Ready to Use Therapeutic Foods (RUTF) for recovery from uncomplicated SAM after 16 weeks of management, compared with an augmented home-prepared foods regimen. The trial will enroll 911 children with uncomplicated SAM and will have enough statistical power to detect a 15% or greater difference in recovery rates between either one of the intervention groups compared with comparison group.
详细描述
India accounts for over half the global burden of severe acute malnutrition (SAM) in the world. While it is important to accelerate efforts to prevent SAM, effective management of children suffering from it is critical for reducing child mortality and achieving MDG1 and MDG4.
Available evidence mostly from studies in Africa suggest that home based management of uncomplicated SAM with Ready to Use Therapeutic Foods (RUTF) is at least as efficacious as facility-based management and that locally produced RUTF is as efficacious as centrally produced RUTF. More evidence on efficacy and effectiveness of home based management using RUTF is needed to decide if this intervention offers substantial advantages over home-prepared foods in the Indian settings. Additionally, there is a demand to generate evidence of efficacy of locally produced RUTF as compared to that of centrally produced RUTF. These issues can only be resolved through a well designed randomized controlled trial.
This project therefore aims to assess the efficacy of three options under consideration in India for home management of SAM. The investigators propose to conduct a multi-center randomized controlled trial to determine the efficacy of two community-supported home-based regimes using centrally or locally produced Ready to Use Therapeutic Foods (RUTF) for recovery from uncomplicated SAM after 16 weeks of management, compared with an augmented home-prepared foods regimen. The trial will enroll 911 children with uncomplicated SAM and will have enough statistical power to detect a 15% or greater difference in recovery rates between either one of the intervention groups compared with the comparison group.
Participants: The study will be conducted in three sites - urban slums and resettlement colonies in the national capital region, rural (predominantly tribal) Rajasthan, rural and urban Tamil Nadu. Field workers will survey the study area to measure mid-upper arm circumference (MUAC) in children 6 to 59 months of age and refer children with MUAC less than 13 cm to a study clinic. At the study clinic, anthropometric measurements will be taken and children with weight for height less than -3 SD of the WHO standards or oedema of both feet will be offered participation in the study.
Intervention and Comparison Regimes for Home Management of SAM
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
- 否
入选标准
- •Age 6 to 59 months
- •SAM, defined as Weight for height less than -3 SD of WHO standard or oedema of both feet or both.
排除标准
- •Complicated SAM defined as child with SAM having signs of severe illness requiring hospitalization
- •Known allergy to animal milk or peanuts
- •Likely to leave the study area permanently in the next 16 weeks
结局指标
主要结局
Recovery by 16 weeks after enrollment (defined as achieving weight for height greater than or equal to -2 SD and absence of oedema of both feet)
时间窗: Weekly till recovery or 16 weeks after enrollment, whichever is earlier
次要结局
- Mortality and hospitalizations(Weekly till 16 weeks or recovery and at end of sustenance phase)
- Rate of weight gain (grams/kg body wt/day)(From enrollment till recovery or 16 weeks whichever is earlier)
- Time required to reach recovery(From enrollment till recovery or 16 weeks whichever is earlier)
- Íncidence and prevalence of diarrhea, ARI and fever during treatment phase(From enrollment till recovery or 16 weeks whichever is earlier)
- Proportion of children with weight for height greater than or equal to -2 SD and absence of oedema of feet(At the end of sustenance phase)
- Cost of three feeding regimens(Enrollment to end of treatment phase)
- Feedback from families, health care providers and ICDS functionaries about the feeding regimens regarding perceptions and feasibility of use(Enrollment to end study)
- Factors which affect recovery(At 16 weeks post enrolment in those that have not recovered)
- Perception of families regarding anganwadi centre experiences at the end of sustenance phase(from end of treatment phase to end of sustanence phase)
研究者
NBhandari
Director
Society for Applied Studies