Preventing Atopic Dermatitis and ALLergies in Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,701
- 试验地点
- 2
- 主要终点
- Atopic dermatitis (AD)
研究概览
简要总结
The primary objective is of the PreventADALL study is to test if primary prevention of allergic diseases is possible by simple and low cost strategies, and secondary to asses the impact of xenobiotic exposure and microbiota in and on the body and the environment on allergic disease development.
The secondary objective is an exploratory focus to investigate early life risk factors for development of non-communicable diseases, including asthma and allergic diseases as well as for diseases that may share common risk factors, including cardiovascular disease, obesity and diabetes.
Design: A multi-national population-based prospective birth cohort with a factorial designed randomized controlled intervention trial of two clinical interventions; skin care 0-9 months and early food introduction by 3-4 months, thereafter observation only.
Recruitment in three cities (Oslo, Ostfold and Stockholm) of approximately 2500 mother-child pairs is done in two steps; first pregnant women are recruited and enrolled at the 18-weeks ultrasound investigation (n=approximately 2700) and thereafter their new-born babies are included.
Randomization into four groups is done by the postal code or "township" to ensure all four intervention-groups within each "township".
Visits for biological and environmental sampling, observations and investigations will be at the relevant pediatric departments (at 3-6-12-24-36 months of age) and through childhood into adulthood thereafter, provided sufficient funding.
详细描述
The PreventADALL study is a long term prospective birth cohort study, with an intervention aspect designed as a randomized clinical trial (RCT), and an exploratory aspect, enrolling mother-child pairs by including pregnant women, allowing for intrauterine investigations of the baby and maternal factors during pregnancy, and thereafter including their new-born babies for long-term follow-up investigations.
With the knowledge that allergic diseases often manifest in early infancy, interventions will be carried out as early as possible to investigate if allergic diseases can be prevented. Two interventions, early and systematic introduction to common foods, and early skin care are carried out within the first four months and the first nine months of life, respectively.
Inclusion/Exclusion criteria:
Ante-natal inclusion, step 1: All mothers to-be at 18 weeks ultrasound investigation with sufficient language skills (Norwegian or Swedish), gestational age: at least 16-22 weeks. Exclusion: Plans to move further than reasonable travel distance from any of the participating hospitals within the first year of the offspring's life.
Inclusion of the child, step 2: Live-born babies of gestational age 35.0 weeks or more (including multiple pregnancies), maternal/parental willingness to participate in the study Exclusion criteria child: 1) severe neonatal cardiac, pulmonary, neurological, dermatological disease or other disease that may influence the outcomes 2), plans to move further than reasonable travel distance away from any of the participating hospitals within the first nine months of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
At all investigations, skin scoring is performed prior to any information from the study participants parents of intervention group. Also, no baths are allowed within 24 hours of investigation, to fascilitate blinding of the investigator to interventional allocation.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The study enrolls Mother-child pairs in two steps; first mother, thereafter her new-born baby.
- •Inclusion Criteria:
- •Ante-natal inclusion, step 1: All mothers to-be at 18 weeks ultrasound investigation with sufficient language skills (Norwegian or Swedish), gestational age: at least 16-22 weeks.
- •Exclusion: Plans to move further than reasonable travel distance from any of the participating hospitals within the first year of the offspring's life.
- •Inclusion of the child, step 2: Live-born babies of gestational age 35.0 weeks or more (including multiple pregnancies), maternal/parental willingness to participate in the study
排除标准
- •Exclusion criteria child: 1) severe neonatal cardiac, pulmonary, neurologic, dermatologic disease or other disease that may influence the outcomes 2), plans to move further than reasonable travel distance away from any of the participating hospitals within the first nine months of life.
- •Non-willingness to participate, 4) More than two foetuses
研究组 & 干预措施
Observation only
Observation only
Food intervention
Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age
干预措施: Food intervention (Other)
Skin care
Intervention: regular baths with bath-oil 0.5-9 months of age
干预措施: Skin care (Other)
Food intervention and skin care
Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age Intervention: regular baths with bath-oil 0.5-9 months of age
干预措施: Food intervention (Other)
Food intervention and skin care
Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age Intervention: regular baths with bath-oil 0.5-9 months of age
干预措施: Skin care (Other)
结局指标
主要结局
Atopic dermatitis (AD)
时间窗: AD 0-12 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding
AD by international standards,
Food allergy to any intervention allergen
时间窗: 0-36 months, assessed first at 36 months, with follow-up investigations at intervals up to year 2044, provided funding
By clinical relevant reactions, intolerance to foods and food challenges, when needed
次要结局
- Asthma (bronchial obstruction in year 1-2)(first at 0-12 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding)
- Food allergy to any other allergen(0-36 months, assessed first at 36 months of age, with follow-up investigations at intervals up to year 2044, provided funding)
- Anaphylaxis(0-36 months, assessed first at 36 months of age, with follow-up investigations at intervals up to year 2044, provided funding)
- Rhinitis/Allergic rhinitis(12-36 months, with follow-up investigations at intervals up to year 2044, provided funding)
- Allergic sensitisation (yes/no as well as quantitative, by skin prick test and s-IgE)(first at 6 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding)
研究者
Karin C. Lødrup Carlsen
Professor MD, PhD
Oslo University Hospital