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临床试验/NCT02486523
NCT02486523已完成不适用

Benefits of a Household WASH Package to Community-based Management of Acute Malnutrition (CMAM) Program, Chad

Action Contre la Faim1 个研究点 分布在 1 个国家目标入组 1,572 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,572
试验地点
1
主要终点
Difference in the proportion of post-recovery relapse cases

研究概览

简要总结

The objective of the research is to assess the effectiveness of adding a Household WASH component to the standard outpatient treatment of severe acute malnutrition.

Study design: cluster-randomized controlled trial comparing two interventions:

  1. Control group: outpatient management of children diagnosed for severe acute malnutrition only
  2. Intervention group: outpatient management of children diagnosed for severe acute malnutrition + "household WASH package"

2000 children, aged between 6 and 59 months, admitted to 20 OTP (Outpatient Therapeutic Program) centers for SAM will be included into the study and followed for 8 months (2 months of treatment, and 6 months after successful discharge).

详细描述

The Action Contre la Faim (ACF) nutrition project in Kanem started in 2008, and now is set up in 35 health facilities divided across 2 health districts: Mao and Mondo. The management of severe acute malnutrition is done in both OTP (Outpatient Therapeutic Programme) and in TFC (Therapeutic Feeding Center). Between the treatment of SAM in OTPs and TFCs, and the number of curative consultations, the total number of beneficiaries is expected to be 45,065 in 2014 (without double counting).

Clear evidence exists that some Water, Sanitation and Hygiene (WASH) interventions can successfully prevent diarrhea. For instance, interventions aiming at improving water quality at household level or at promoting hand washing with soap do reduce significantly diarrhea incidence. Estimations showed that WASH interventions have a small but measurable benefit on length growth, but not on weight or weight/height. Yet, to our knowledge, no impact of WASH interventions has been assessed, neither during nutritional rehabilitation where children are particularly vulnerable to infections, nor after discharge where immune recovery is still incomplete.

In the context of nutritional rehabilitation of SAM (Severe Acute Malnutrition), the investigators hypothesize that improving water quality and hygiene-related care practices at household level would decrease incidence of WASH-related infections, such as diarrhea, nematode and environmental enteropathy. As such, it would improve weight gain, decrease relapses after successful discharge, and overall, could decrease over time the incidence of acute malnutrition in the community.

The proposed WASH intervention will be added to already existing nutritional activities and it will include: i/ Household water treatment and hygiene kit (water container, water disinfection consumables, soap, cup, hygiene promotion leaflet) provided at beginning of SAM treatment; ii/ sessions of Hygiene promotion provided weekly at health center level iii/ Household visits and hygiene sessions made during the treatment; // group discussion on hygiene and care practices made with mother at community level after successful discharge.

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

入选标准

  • 未提供

排除标准

  • Signs of medical complications requiring inpatient management,
  • Bilateral oedema (+++),
  • Transfer from another OTP: treatment already started and child has a identification number (ID) for SAM
  • Refusal of caretaker to participate
  • Children from families outside the health center coverage

结局指标

主要结局

Difference in the proportion of post-recovery relapse cases

时间窗: 2 months and 6 months after successful OTP discharge

This is a dichotomous variable based on whether a child discharged as cured from the OTP program has a new event of acute malnutrition during the 6 months following the discharge. The relapse proportion for each group = \[Total number of relapsing children\] / \[total number of discharged children that have been followed up\] Relative reduction of 42% (from 12% to 7%) is expected.

次要结局

  • Difference in the average weight gain at the OTP discharge(an expected average is between 7 and 8 weeks)
  • Diarrhoea Incidence(up to 6 months follow up)
  • Difference in the length of stay in the OTP(an expected average is between 7 and 8 weeks.)
  • Difference in the anthropocentric measurements (WHZ, HAZ, WAZ)(up to 6 months after OTP discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mathias Altmann

Dr

Action Contre la Faim

研究点 (1)

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