Use of Energy Dense Food (EDF)/ Locally prepared therapeutic food for community based management in children aged 6- 59 months with Severe Acute Malnutrition
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. Weight gain: change in g/kg/day between baseline and recovery or 16 weeks of intervention, whichever will be earlier. We will also document the change in weight standard deviation scores from baseline and at different time points of follow up.
研究概览
简要总结
Severe Acute Malnutrition (SAM) is defined by weight-for-height/length Z- score below -3 SD of the median WHO child growth standards AND/ OR MUAC <11.5cm AND/OR by the presence of bilateral pitting edema. SAM significantly increases the risk of death in children under- five years of age. The current prevalence of SAM in India (NFHS 5) is 7.7% with a rise of 0.2% from NFHS-4 in 2016 (7.5%). Prevalence of SAM in Haryana is 4.4% (NFHS 5). In India, children with SAM and medical complications should be admitted in health facility. Approximately 85-90% of severely malnourished children who do not have any medical complications can be taken care of on as outpatient basis in a community setting, using Energy Dense Food (EDF)- Augmented THR and other home based food items and routine medicines to treat simple medical conditions. Currently there is no guidelines by government of India on management of Community based Management of Acute Malnutrition (CMAM) children. However, many countries (60+) and States (12) in India developed specific CMAM guidelines.WHO released guidelines in 2007 that recommends Ready to Use Therapeutic Food (RUTF) for homebased management of uncomplicated SAM, but acceptance of this recommendation is limited in India. Locally produced RUTF/ Augmented Take Home Ration using indigenous foods may be less expensive and more sustainable if its efficacy could be proved. Reviews, including the most recent Cochrane review (2013), recommend well-designed, adequately powered, pragmatic randomised trials to compare treatment options for home-based management of uncomplicated SAM. Currently the state of Telangana in India has started the Supervised Supplementary Feeding program to strengthen the CMAM component and introduced ‘Balamrutham Plus’, a calorie and protein dense fortified food for treatment of SAM and Moderate Acute Malnutrition (MAM).In Haryana, Mewat is an aspirational district of government of India where the prevalence of SAM is 7.1 %. Thus, the study will be conducted to compare the efficacy of Balamrutham Plus Vs standard RUTF on the nutritional status of children 6 to 59 months age with uncomplicated SAM in Mewat district, Haryana. Also, the study aims to look at the holistic approach for community based management of acute malnutrition (CMAM) among uncomplicated SAM children starting from exploring the factors effecting SAM and to critically appraise the evidence and policy environment around CMAM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Month(s) 至 59.00 Month(s)（—）
- 性别
- All
入选标准
- •Children aged
- •59 months with Severe Acute Malnutrition based on following criteria: a) Weight for length/height z-score (WHZ) <-3SD b) No Bilateral pitting oedema and no medical complication
- •Children whose families were likely to remain in the study area over the next 4-5 months, and residing in the same at least for the past six months.
- •Children with Severe Acute Malnutrition passing appetite test.
- •Children with above criteria and parent gives informed consent to participate.
排除标准
- •Children with Severe Acute Malnutrition and having any acute medical complications (they will be referred to facility based care for initial management / stabilization).
- •Bilateral pitting oedema of any grade.
- •Children where parent rejects to participate.
- •Children with severe illness requiring hospitalisation, haemoglobin <5 g/dL, and who are unable to consume the appetite test feed.
- •Children with congenital anomalies, cerebral palsy, neurogenerative disorders.
- •Children’s who do not have living parents.
- •Children with Co-morbid illness or systemic diseases, malabsorption, irritable bowel syndrome or celiac diseases, chronic diarrhea and chronic infections (HIV, Tuberculosis).
- •Children who have undergone any major surgery in last 6 months.
结局指标
主要结局
1. Weight gain: change in g/kg/day between baseline and recovery or 16 weeks of intervention, whichever will be earlier. We will also document the change in weight standard deviation scores from baseline and at different time points of follow up.
时间窗: 16 weeks
2. Recovery/ Discharged/ Cured: WHZ ≥ −2 SD of the WHO standards and absence of oedema of feet at the end of 16-week follow-up
时间窗: 16 weeks
3. Relapse: children hospitalized or develop medical complication at any stage that requires admission (transferred out) and lost to follow-up over 16 weeks of intervention
时间窗: 16 weeks
4. Non responder: Cases who do not meet discharge criteria after 16 weeks
时间窗: 16 weeks
次要结局
- 1. Mortality rate(2. Height gain)
研究者
Dr Kapil Yadav
All India Institute of Medical Sciences, AIIMS, New Delhi