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临床试验/NCT01917734
NCT01917734已完成不适用

Evaluation of the Effectiveness of an Integrated Program for the Management of Severe Acute Malnutrition in Children in Madhya Pradesh, India

Victor M. Aguayo1 个研究点 分布在 1 个国家目标入组 2,740 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,740
试验地点
1
主要终点
Recovery

研究概览

简要总结

The purpose of this study is to assesses the effectiveness of an integrated model for the management of severe acute malnutrition (IM-SAM) in India comprising facility- and community-based care and using locally-adapted protocols

详细描述

Madhya Pradesh's program for the provision of care to children with severe acute malnutrition (SAM) was initiated in the district of Shivpuri in January 2006. By January 1, 2010, Madhya Pradesh National Rural Health Mission (NRHM) had established 199 Nutrition Rehabilitation Centers (NRCs) where children were receiving therapeutic care following protocols based on the guidelines for the management of SAM by the World Health Organization (WHO)and the Indian Academy of Pediatrics.

The detection of children with SAM was ensured in the communities by frontline workers in the context of monthly growth monitoring and promotion sessions. Once at the NRC the age, weight, height, mid-upper arm circumference (MUAC) and presence of bilateral pitting edema were determined for each child. SAM was defined as per WHO recommendations by the presence of bilateral pitting edema or the presence of severe wasting. Severe wasting was defined by a MUAC below 115 mm and/or a weight-for-height z-score (WHZ) < - 3 of the median WHZ in WHO Child Growth Standards. All children 6-59 months with bilateral pitting edema, and/or WHZ < - 3 and/or MUAC < 115 mm were admitted to the NRC.

Once children were admitted to the NRC, a medical doctor conducted a clinical examination on them to detect the presence of medical complications (lethargy, pneumonia, dehydration, fever, tuberculosis, and/or severe anemia) using the criteria for the Integrated Management of Neonatal and Childhood Illnesses (IMNCI).

As per protocol, children with edema, and/or medical complications, and/or poor appetite were fed locally-prepared F-75 therapeutic milk every two hours for 48 hours (stabilization phase) while their medical complications were treated. After completion of the initial 48 hours, children were fed alternatively F-75 and locally-prepared F-100 therapeutic milk six times a day for about 48 hours (transition phase). After the transition phase, children were fed F-100 and locally-produced lipid-based therapeutic food (TF) with the aims of initiating rapid weight gain (rehabilitation phase). Children with normal appetite and free of medical complications entered the rehabilitation phase from the day of admission. All children received a course of broad spectrum antibiotic.

Upon the completion of a prescribed 14-day stay in the NRC, children were transitioned to the community phase of the program where they were followed up by community-based frontline workers. Frontline workers were to ensure that the child benefited a Supplementary Nutrition Program (SNP) and returned for a follow up visit at the NRC every 15 days during the 60 days following discharge. At the four follow up visits, children's weight gain was assessed and mothers were counseled on child feeding and care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Age 6-59 months
  • Clinical diagnosis of with bilateral pitting oedema
  • Anthropometric diagnosis of severe wasting (WHZ < - 3 and/or MUAC < 115 mm)

排除标准

  • Severe congenital conditions whose clinical management required highly specialized skills only available ar the district hospital
  • Severe pathological conditions whose clinical management required highly specialized skills only available ar the district hospital

结局指标

主要结局

Recovery

时间窗: 74 days

Weight gain \>= 15% of initial weight gain

Discharged

时间窗: 74 days

Proportion of children completing a 14-day stay in the NRC, transitioned to the community phase of the program and atteding at least two of the four community-based follow up visits.

次要结局

  • Weight gain(74 days)

研究者

发起方
Victor M. Aguayo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Victor M. Aguayo

Chief, Child Nutrition and Development, India

UNICEF

研究点 (1)

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