Short-term Topical Application to Prevent Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- Cumulative incidence of atopic dermatitis at 12 months.
研究概览
简要总结
This is a randomised, open-label, controlled study designed to investigate the effect of short-term neonatal skin barrier protection using a commercially available moisturiser on the prevention of atopic dermatitis and food allergy in high risk children.
详细描述
Eczema, also known medically as Atopic Dermatitis (AD) is the most common skin disease of childhood, affecting 20% of Irish children, and is a general term for a group of skin conditions that cause the skin to become dry, red, itchy and inflamed. AD is often the first manifestation of atopic comorbidities including food allergy, asthma and allergic rhinitis. Recently published studies suggest that skin barrier preservation, with topically applied moisturisers in the first year of life, reduces the incidence of AD. Our own data suggests that an earlier window for this skin barrier protection may exist.
This study is a randomised, open-label, controlled study and will investigate the effect of short-term neonatal skin barrier protection on the prevention of AD and food allergy in high risk infants. Infants with at least one parent with a positive history of atopic disease (AD, allergic rhinitis, asthma or food allergy) will be eligible for recruitment.
The first study visit will take place within approximately 4 days of birth in the postnatal wards. At this visit, infants will be randomised to either treatment with skin barrier protection using a commercially available moisturiser or to standard routine skincare with no moisturiser from as soon as possible after birth until 2 months of age. This visit will also involve measurements of neonatal trans-epidermal water loss (TEWL) and natural moisturising factor (NMF) to assess skin barrier function and structure. Skin swabs will also be taken for microbiome and immune biomarker analysis.
Follow-up assessments will take place at 2, 4 and 8 weeks, 6 and 12 months. Each visit will include a physical examination of the infant's skin, including TEWL and NMF measurements, and a questionnaire on infant health, bathing and skincare.
Infant skin swabs will be taken again at 8 weeks and 12 months. A research nurse or doctor, blind to treatment allocation, will administer standardised assessments for the presence (yes/no), extent and severity of AD at 6 and 12 months. Suspected cases of food allergy will be investigated using skin prick testing (SPT) and oral food challenges.
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)
盲法说明
Research personnel responsible for conducting atopic dermatitis assessments during study follow-up visits will be blinded to the treatment allocation.
入排标准
- 年龄范围
- 0 Days 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy full-term infants, gestational age >36+6 weeks.
- •Infant has at least one parent with self-reported atopic dermatitis, food allergy, allergic rhinitis or asthma.
- •Not requiring admission to the Neonatal Unit.
排除标准
- •No parental history of atopic disease.
- •Admission to the Neonatal Unit for issues other than the establishment of normal feeding.
- •Being administered oral or parenteral antibiotics.
- •Receiving phototherapy for hyperbilirubinaemia.
- •Sibling, including twin, already recruited.
- •Other serious health issues (e.g. abdominal wall defects, congenital heart disease etc.) or a severe widespread skin condition (e.g. collodion).
- •Any condition that would make the use of skin barrier protectant inadvisable or not possible (e.g. ankle talipes or developmental dysplasia of the hip, requiring a Pavlik's harness or casts).
- •Participation in any other clinical trial of an investigational medicinal product.
结局指标
主要结局
Cumulative incidence of atopic dermatitis at 12 months.
时间窗: 12 months
Cumulative incidence of IgE-mediated food allergy at 2 years
时间窗: 2 years
次要结局
- Longitudinal changes in natural moisturising factor (NMF) in the stratum corneum from birth to 12 months.(Birth to 12 months)
- Changes in skin biomarker profile between study over the first year of life.(Skin swabs for biomarker analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.)
- Longitudinal changes in transepidermal water loss (TEWL) from birth to 12 months(Birth to 12 months)
- Microbial diversity and richness of the cheek and antecubital fossa (study subset).(Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.)
- Comparison of skin biomarker profiles between the intervention and control groups.(Skin swabs for biomarker analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.)
- Changes in skin microbial diversity and richness over the first year of life.(Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.)
- Comparison of microbial diversity and richness between the intervention and control groups.(Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.)
- Skin biomarker profile analysis of the cheek and antecubital fossa (study subset).(Skin swabs for biomarker analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.)
研究者
Jonathan Hourihane
Principal Investigator
University College Cork