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临床试验/NCT02671786
NCT02671786已完成不适用

Community Based Management of Severe Malnutrition in Under 5 Children in Tribal Area of Melghat, Maharashtra- Cluster Randomized Control Field Trial

MAHAN Trust2 个研究点 分布在 1 个国家目标入组 824 人开始时间: 2011年5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
入组人数
824
试验地点
2
主要终点
Recovery rate of SAM (Severe Acute Malnutrition), SUW (Severe Underweight) and IAP Grade III,IV

研究概览

简要总结

Provision of community based health care to severely malnourished children (Age group: 6 months through 5 years) in 16 tribal villages by trained semi-literate village health workers.

  1. Treatment of severely malnourished children.
  2. Growth monitoring of all children below the age of 5 years.
  3. Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc.
  4. Management of resistant or relapsed severely malnourished cases by pediatrician.
  5. Intensive behavior change communication of parents of children below the age of 5 years for proper nutrition.

详细描述

1. Title of project: SAMMAN- Community based management of severe malnutrition in under 5 children in tribal area of Melghat region

2. Name of Institution: MAHAN Trust, Address: Mahatma Gandhi Tribal Hospital, Karmagram . Utavali, tehsil- Dharni, Melghat (Amaravati)

3. Objectives -

  1. To reduce the child mortality (in the age of group of 6 months to 5 years) due to severe malnutrition in tribal area of Melghat by 35% in usual residents population of 15000 (from 16 villages) over a period of 3 years.
  2. To reduce the prevalence of severe malnutrition (in the age of group of 6 months to 5 years) by at least 35% in usual residents population of 15000 from 16 villages in tribal area of Melghat over a period of 3 years.
  3. To achieve Case fatality rate of 2 % of treated severely malnourished children.
  4. Need and rational of the project :

Melghat is a hilly difficult to approach tribal forest terrain in Amaravati district of Maharashtra, India . Population is 2,80,000 & 75% of them are tribal. Most of the tribal (>90 %) are farmers or laborers, living below poverty line(>75%) & very hard life in huts without electricity (>90%) & illiterate (>50%). Medical facilities are worst in Melghat as compared to rest of Maharashtra. A detailed study conducted by MAHAN showed that more than 20% of tribal children are severely malnourished and the under 5 children mortality rate is more than 100 per 1000 live births due to lack of proper nutrition, medical facilities, superstitions & reluctance for hospitalization of severely malnourished children. There is an immediate need to fight severe malnutrition in children between the ages of 6 months to 5 years. This project is being implemented as a pilot project in 16 villages of Melghat which has potential for replication in all tribal and rural part of India. 5. Methodology Study design: The study is a cluster randomized parallel group controlled field trial Study area: 35 tribal villages selected from 5 clusters of Melghat by lottery method divided into intervention and control area.

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 60 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children suffering from severe malnutrition as per weight for height criteria (WHO), weight for age criteria (WHO), MUAC (WHO), IAP grade III & IV. Defacto method.

排除标准

  • Children who have failed in appetite test and cannot tolerate oral F75 food. Also,
  • Parents, guardian refuse to give consent.

结局指标

主要结局

Recovery rate of SAM (Severe Acute Malnutrition), SUW (Severe Underweight) and IAP Grade III,IV

时间窗: At the end of therapeutic cycle of 3 months

Case fatality rate of treated severely malnourished children

时间窗: At the end of therapeutic cycle of 3 months

Prevalence of severe malnutrition (SAM, SUW, IAP Grade III,IV)

时间窗: Over the period of 3 years

次要结局

  • Child mortality rate ( 6 months to 60 months age group)(3 years)

研究者

发起方
MAHAN Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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