Topical Emollient Therapy in the Management of Severe Acute Malnutrition: A Randomized Controlled Clinical Trial in Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- changes of body weight
研究概览
简要总结
The investigators hypothesize that the absorption of topically applied EFA-containing emollient (SSO) into the skin and thence into the bloodstream in children with SAM will improve skin barrier function and accelerate weight gain and clinical rehabilitation beyond that possible through normal standard-of-care
详细描述
A child with SAM, in addition to wasting will often present with infection, hypothermia, dehydration and electrolyte imbalance - complications attributable, at least in part, to compromised skin barrier function. Essential fatty acid (EFA)-containing emollients such as sunflower seed oil (SSO) have been shown to augment skin barrier function, reduce transepidermal water loss (TEWL) and risk of bloodstream infection and mortality, and promote weight gain in preterm infants. Recent research from rural Bangladesh showed very low levels of EFAs in young children in the general population. It is believed that EFA levels will be further depleted in children with SAM. So the investigators aim to demonstrate the feasibility of topical applications of SSO to children with SAM, and to measure clinical impact of emollient therapy with SSO on skin barrier function, skin condition, EFA levels in blood, weight gain, co-morbidities (e.g., pneumonia, sepsis), and time to complete acute rehabilitation from SAM, in addition to the benefits of normal standard-of-care.
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
- 2 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent or legal guardian is willing and able to provide written informed consent for the subject to take part in the trial and comply with an inpatient stay of at least 10 days.
- •Children aged 2-24 months inclusive diagnosed with SAM (weight-for-length Z score <-3 or bilateral pedal edema) admitted in the Dhaka Hospital of icddr,b, Dhaka, Bangladesh
- •Willing to suspend usual home skin care treatments for the duration of study
排除标准
- •Consent refusal
- •Life threatening health conditions such as septic shock and altered consciousness on admission; congenital problems (congenital heart disease or known metabolic disorders, chromosomal abnormalities, renal failure, etc.); any known chronic disease including tuberculosis, HIV infection
- •History of drug or other allergy or any condition that may complicate the interpretation of safety or efficacy such as dermatitis which, in the opinion of the investigator, contraindicates participation in the trial, or know hypersensitivity to SSO
- •The child is in care (no longer looked after by their parent or legal guardian)
- •Participation in another study
结局指标
主要结局
changes of body weight
时间窗: Baseline and 10th day
Body weight will be measured after 10 days of intervention
次要结局
- Skin condition changes(Baseline and 10th day)
- Time to discharge from acute illnesses(through study completion, an average of 5 days)
- Reduction in TEWL(baseline and 10th day)
- Serum CRP level(Baseline and 10th day)
- Serum Cytokines level(Baseline and 10th day)
- Serum essential fatty acids (EFAs) level(Baseline and 10th day)
- Reduction of rate of nosocomial infections between cases and controls(through study completion, an average of 10 days)