Effectiveness of Context-adapted Alternative Feeding Regimen on Recovery of Children Aged 6-59 Months From Moderate Acute Malnutrition and Uncomplicated Severe Acute Malnutrition in Bangladesh. A Cluster Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 560
- 试验地点
- 2
- 主要终点
- Recovery rate (%)
研究概览
简要总结
In spite of the large burden of acute malnutrition in the country, the Community-based Management of Acute Malnutrition (CMAM) protocol approved in Bangladesh highly deviates from the WHO normative guidance, in that it does not support the use of any currently existing nutritional products for Moderate Acute Malnutrition (MAM) cases: it relies solely on nutrition counselling. On another hand, some non-governmental organizations (NGOs) are implementing programs making a standard use of specialized nutritional products, such as nutritional supplements like Wheat Soy Blend (WSB)++ to manage MAM cases, in children of Forcibly Displaced Myanmar Nationals (FDMNs) in the refugee camps situated at the south-eastern region of the country and in some crisis-affected districts as well.
The "no-food" CMAM policy for MAM is decreasing the cost of treatment, yet this may undermine effectiveness and impact. In this context, policy makers need evidence regarding context specific, effective and scalable interventions for CMAM.
This cluster randomized control trial (cRCT) will be conducted in the host communities in Teknaf and Ukhiya sub-districts of Cox's Bazar district of Bangladesh among children aged 6-59 months suffering from MAM who will be assigned to receive either of the 2 different treatment packages for a period of 4 months (120 days). Then followed up for 6 months (180 days) post treatment completion. Each arm will consist of 280 children with MAM. Both the arms will receive nutrition counselling along with the study intervention, as follows:
In the first arm, the treatment packages for children with MAM will include a standard use of specialized nutritional products developed to address the nutritional needs of these children in acute crisis/emergency settings and widely used internationally: children with MAM will receive WSB++ with nutrition counselling for a period of 4 months (120 days),.
In the second arm, children with MAM will receive 15 MNP with improved nutrition counselling for a period of 4 months (120 days).
A cluster sampling technique will be used to enroll participants. Each Community Clinic and Union Health & Family Welfare Centers will serve as unit of cluster for the randomization.
Primary outcome variables are: 1) Daily weight gain (g/kg/d) between enrolment and end of the treatment period. 2) Recovery rate (%) at the end of the treatment period.
详细描述
Background
Burden:
Acute Malnutrition (AM) which is also known as 'wasting' in children under five years of age is a major and significant global health problem. It has two forms: i) Severe Acute Malnutrition [(SAM, defined as weight-for-height/length z-score (WHZ/WLZ) less than -3 standard deviations (SDs) from the median of reference population and or Mid-Upper Arm Circumference (MUAC) < 115mm, and or presence of bipedal edema)], and ii) Moderate Acute Malnutrition [(MAM, defined as WHZ/WLZ between -3SDs and <-2SDs and or MUAC ≥ 115mm to <125mm)]. It is estimated that more than half of all under five deaths are associated with undernutrition. Both MAM and SAM pose serious consequences, leading to increased morbidity and mortality, impaired intellectual development, increased risk of non-communicable diseases (NCDs) in adulthood, and suboptimal adult work capacity. Children with SAM have approximately nine times and children with MAM have approximately three times higher risk of mortality due to common communicable diseases than if they were well-nourished. A MAM child is additionally at higher risk of developing SAM if their health and nutritional condition is not monitored. The recent Lancet analysis estimated that in 2020, the COVID19 pandemic exacerbated the problem of AM with an additional 6.7 million children - equivalent to a 14.3% increase in the number of children with wasting. More than half (3.9 million) of these children would be from South Asia alone. Although prevalence of AM in many countries have reduced, still these are far from Sustainable Development Goals (SDGs) target.
Despite Bangladesh already progressed in reduction of AM by more than half between 2007 and 2017, still it has one of the highest prevalence of AM in the world. According to Bangladesh Demographic and Health Survey (BDHS) 2017 prevalence of AM under-5 children was 8.4%, while the multiple indicator cluster survey (MICS) which included a larger sample, found a slight increase from 9.6% in 2013 to 9.8% (1.5 million) in 2019. Of the total AM, 7.5% (1.1-1.2 million) were MAM. It depicts that currently in terms of reducing the prevalence of wasting among children under five to <5 %, Bangladesh has to go far away to achieve the SDG target 2.2 by 2025. It was observed that despite having recovery rate above the minimum standards of >75%, post-discharge relapse rates of AM were very high (78% for MAM 69% while 9% for SAM) in Bangladesh and Southern Ethiopia 72.1% (37.5% for MAM and 34.6% for SAM). Chang et al. 2013 found 27% (17% for MAM and 10% for SAM) relapse cases in Malawi. Therefore, after recovery and discharge a child should be followed up to assess the maintenance of the nutritional status, because it is likely that children who recovered from AM may recur as AM after returning to the same environment.
Knowledge gap:
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
- •Children of either sex, aged between 6-59 months having MUAC <125 mm and/or WHZ/WLZ <-2 SD
- •Absence of edema or morbidities that necessitate hospitalization
- •Children with appetite
- •Mothers/caregivers sign the consent form
- •Willing to bring the child to the study site every two weeks for MAM and have a plan to stay in the community for at least next 9-10 months.
- •Accept the intervention package and home visits for data collection and morbidity follow up
排除标准
- •Bipedal edema
- •MAM with clinically severe anemia, suspected tuberculosis, other chronic diseases or any congenital disorder or deformity, an ongoing episode of diarrhea, a history of persistent diarrhea in the past month.
结局指标
主要结局
Recovery rate (%)
时间窗: 4 months or 120 days
Recovery rate (%) at the end of the treatment period
Free from acute malnutrition
时间窗: 4 months or 120 days
Proportion of children free from acute malnutrition at the end of the treatment period
Rate of weight gain (g/kg/d)
时间窗: 4 months or 120 days
Daily weight gain (g/kg/d) between enrolment and end of the treatment period. If recovery was reached before the full duration of the treatment, daily weight gain will be calculated between enrolment and recovery, without stopping the treatment.
次要结局
- Proportion of non-response, death, defaulter and regression of MAM to SAM(4 months or 120 days)
- Change in lean and fat mass between enrollment and end of the treatment period(4 months or 120 days) and 6 months post-treatment)
- Motor, language, and personal-social development at the end of the treatment period(4 months or 120 days) and 6 months post-treatment)
- Incidence of relapse during a period of 6 months (180 days) post-treatment(6 months or 180 days post treatment)
- Prevalence of concurrent infections at the end of the treatment period(4 months or 120 days) and 6 months post-treatment)
