Effectiveness and Acceptability of Nutritional Rehabilitation Based on Ready-to-use Food in HIV-infected Children and Adolescents in Senegal: The Multicentre SNAC'S Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 主要终点
- Successful nutritional rehabilitation
研究概览
简要总结
Severe (SAM, Body Mass Index-z < -3) and moderate (MAM, -3 ≤ BMI-z < -2) acute malnutrition, highly prevalent in HIV-infected children and adolescents, is an independent risk factor of death, even when antiretroviral treatment (ART) is initiated. The objectives of the SNAC'S study are to assess acceptability and effectiveness of outpatient nutritional rehabilitation, using ready-to-use food (RUF), elaborated in compliance with national and international recommendations and implemented in HIV-infected children and adolescents, under active follow-up in the 12 main pediatric HIV care sites in Senegal and presenting with SAM or MAM.
详细描述
Background:
Severe (SAM, BMI-z < -3) and moderate (MAM, -3 ≤ BMI-z < -2) acute malnutrition, highly prevalent in HIV-infected children and adolescents, is an independent risk factor of death, even when antiretroviral treatment (ART) is initiated. Scaling-up of ART decreased morbimortality in children in low-income settings and thus allowed HIV-infection to become, to some extent, a chronic disease. However, appropriate and targeted nutritional interventions take a long time to be assessed with the aim of their integration in the "global care" of HIV infection, thus jeopardizing in these patients who go through adolescence the successes achieved so far. Many clinical trials reported a greater efficacy of the ready-to-use therapeutic foods (RUTF) in the nutritional rehabilitation compared with standard interventions, among up to five children, with or without HIV-infection. Since 2007, the United Nations recommend their use for the outpatient nutritional rehabilitation of severely malnourished children and since 2009, also in HIV-infected adolescents.
Objectives :
The objectives of the SNAC'S study are to assess acceptability and effectiveness of outpatient nutritional rehabilitation, using ready-to-use food (RUF), elaborated in compliance with national and international recommendations and implemented in HIV-infected children and adolescents, under active follow-up in the 12 main pediatric HIV care sites in Senegal.
Will be specifically assessed:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infected with HIV
- •presenting with severe or moderate acute malnutrition
- •followed-up in one of the 12 study sites
- •written consent of the parent/legal guardian
- •verbal assent of the child
排除标准
- •pregnancy
- •physical and/or mental disability incompatible with the study follow-up
- •living far from the study site (about more than 50km)
结局指标
主要结局
Successful nutritional rehabilitation
时间窗: up to 12 months
the child reach his/her target weight defined as weight-for-height \>= - 2 z-scores in children \< 5years; body mass index for age \>= -2 z-score in children \>= 5 years
次要结局
- long-term effectiveness(6 months)
研究者
Cecile Cames
Principal investigator, Researcher
Institut de Recherche pour le Developpement