A Pilot Study to Determine the Feasibility of Early Emollient Use in Children With High Risk for Atopic Eczema - EARLYemollient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Willingness to participate
研究概览
简要总结
The aim of this pragmatic, parallel group, assessor-blind randomised open-label prospective study is to determine the reasons that motivate parents to enrol or not enrol their child in a randomized, controlled basic emollient trial for the prevention of atopic eczema (AE). Furthermore, this trial intends to test the hypothesis that daily skin barrier enhancement with Lipikar Baume AP+® in newborns at high risk is safe and efficient in preventing AE.
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详细描述
The aim of this trial is to determine the reasons that motivate parents to enrol or not enrol their child in a randomized, controlled basic emollient trial for the prevention of AE. Furthermore, this trial intends to test the hypothesis that daily skin barrier enhancement with Lipikar Baume AP+® in babies at high risk of allergic disease is safe and to estimate the preventive effectiveness of Lipikar Baume AP+® in the prevention of AE in a high risk population.
Objectives:
The primary objectives are to investigate the
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Feasibility:
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Parental willingness to enter a child in a controlled primary prevention trial
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Compliance with intervention
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Safety: incidence of skin-related adverse events and serious adverse events during the study
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Effectiveness:
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
- 1 Day 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant (i.e. the newborn baby) must have a parent or sibling with a history of AE, allergic rhinitis or asthma.
- •Infant in overall good health.
- •Term-born babies
- •Mother at least 18 years of age at delivery and capable of giving informed consent.
排除标准
- •Preterm birth (defined as birth prior to 37 weeks gestation).
- •Previous child randomised to this trial.
- •Major congenital anomaly.
- •Significant inflammatory skin disease at birth (except seborrheic dermatitis).
- •Any immunodeficiency disorder or severe genetic skin disorder.
- •Any condition that would make the use of emollients inadvisable or not possible.
结局指标
主要结局
Willingness to participate
时间窗: 2 years
Willingness of parents to get their child randomized and to adhere to the regimen
次要结局
- Development of AE(2 years)
- Microbiome diversity(2 years)
- Transepidermal water loss(2 years)
研究者
Prof. Dr. Stephan Weidinger
Deputy Head, Department of Dermatology and Allergy
University Hospital Schleswig-Holstein