A Randomised Controlled Trial to Determine Whether Application of Emollient From Birth Can Prevent Eczema in High Risk Children.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,394
- 试验地点
- 16
- 主要终点
- A diagnosis of eczema between 12 and 24 months of age (defined as meeting the United Kingdom (UK) Working Party Diagnostic Criteria for Atopic Dermatitis).
研究概览
简要总结
The primary objective is to determine whether advising parents to apply emollient (moisturiser) to their child's skin for the first year of life in addition to best practice infant skin care advice can prevent or delay the onset of eczema in high-risk children, when compared with a control group who are given the best practice infant skin care advice only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •child has a first degree relative with parental reported doctor diagnosis of eczema, allergic rhinitis or asthma
- •child up to 21 days old
- •consenting adult has the ability to understand English
排除标准
- •preterm birth (defined as birth prior to 37 weeks gestation)
- •sibling (including twin) previously randomized to this trial. If multiple births, the first child will be randomized into the trial.
- •child has a severe widespread skin condition that would make the detection and/or assessment or eczema difficult
- •child has a serious health issue, which, at parent or investigator discretion, would make it difficult for the family to take part in the trial
- •any condition that would make the use of emollient inadvisable or not possible
结局指标
主要结局
A diagnosis of eczema between 12 and 24 months of age (defined as meeting the United Kingdom (UK) Working Party Diagnostic Criteria for Atopic Dermatitis).
时间窗: 24 months
To reflect the chronicity of eczema, these criteria refer to signs and symptoms present over the past year. Applying the criteria at 24 months of age will therefore detect eczema present only between the ages of 12 and 24 months, thus excluding transient eczematous rashes which are common in the first year of life and often reported by parents as "eczema" but less likely to be true atopic eczema
次要结局
- Parental health-related quality adjusted life years.(Upto 24 months)
- Time to onset of eczema(24 months)
- Severity of eczema with EASI eczema severity scales(Up to 24 months)
- Child health-related quality adjusted life years.(Upto 24 months)
- Presence of other allergic diseases using parental reports, allergic sensitization and confirmed diagnosis(Upto 24 months)
- Presence of parental report of eczema between birth and 24 months.(Up to 24 months)
- Presence of visible eczema at 24 months (skin examination by researcher).(24 months)
- Cost or treatments- health economic outcomes(Up to 24 months)
- Severity of eczema with POEM eczema severity scales(Up to 24 months)