Topical Treatment With Fresh Human Milk Versus Emollient on Atopic Eczema Spots in Young Children: A Small, Randomized, Split Body, Controlled, Blinded Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 主要终点
- Proportional change in area of the eczema spot from baseline
研究概览
简要总结
The aim of this small pilot study is to assess the potential effects and risks of applying fresh human milk locally on eczema spots in children with atopic eczema. This is a split body, controlled, randomized and physician blinded pilot study, of children with atopic eczema with two similar contralateral eczema spots having a mother breastfeeding the child or a sibling. Fresh expressed milk and emollient is to be applied on the intervention spot and emollient alone on the control area, three times a day for four weeks. Severity and area of the eczema spots is evaluated weekly, and samples from milk and the spots were analysed weekly with respect to bacterial colonisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with atopic eczema according to Hanifin and Rajkas criteria with a mother breastfeeding the child or a sibling.
- •The eczema spots in the treatment and control areas were to be similar in features and extent as well as being localized on contralateral parts of the body.
排除标准
- •Children were excluded if the severity of the eczema spots indicated need for treatment with antibiotics and/or steroids.
结局指标
主要结局
Proportional change in area of the eczema spot from baseline
时间窗: four weeks
The primary outcome was proportional change in area (cm2) of the eczema spot from baseline, as measured by Visitrak™ (Smith \& Nephew), a portable device used to measure the area of wounds.
次要结局
- Transmission of bacteria from mother's milk to eczema spots in the child(four weeks)
研究者
Teresa Løvold Berents
Medical doctor
Oslo University Hospital