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The Childhood Asthma Prevention Study (CAPS): Design and Research Protocol of a Randomized Trial for the Primary Prevention of Asthma.

Controlled Clinical Trials(2018)

Univ New South Wales | Univ Sydney | Univ Calif Berkeley | Karolinska Inst | Western Sydney Univ | QIMR Berghofer Med Res Inst | Univ Hosp Zurich

Cited 120|Views14
Abstract
The Childhood Asthma Prevention Study is a randomized controlled trial to measure whether the incidence of atopy and asthma can be reduced by house dust mite allergen reduction, a diet supplemented with omega-3 fatty acids, or a combination of both interventions. Six hundred and sixteen pregnant women whose unborn children were at high risk of developing asthma because of a family history were randomized prenatally. Study groups are as follows: Group A (placebo diet intervention, no house dust mite reduction), Group B (placebo diet intervention, active house dust mite reduction), Group C (active diet intervention, no house dust mite reduction), and Group D (active diet intervention, active house dust mite reduction). The house dust mite reduction intervention comprises use of physical and chemical methods to reduce allergen contact. The dietary intervention comprises use of a daily oil supplement from 6 months or at onset of bottle-feeding, and use of margarine and cooking oils based on sunflower or canola oils to increase omega-3 dietary intake. Data is collected quarterly until the infant is 1 year old and then half yearly until age 5 years. Questionnaires are used to collect respiratory illness history and information about diet and home environment. Dust is collected from the child's bed and bedroom and playroom floors. Blinded assessments are conducted at 18 months, 3 years, and 5 years. Skin prick tests to common allergens, blood tests, and detailed illness, medication use, and vaccination histories are collected. Primary outcomes will be the development of allergic sensitization and the presence and severity of asthma. This study is designed to measure the effectiveness of allergen reduction and dietary supplementation, both separately and in combination, for the primary prevention of atopy and asthma. The results of this study may have important implications for public health policies to reduce the incidence of childhood asthma. Control Clin Trials 2001;22:333-354
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Asthma,atopy,allergen avoidance,benzyl benzoate,fatty acid supplementation,house dust mite,primary prevention of asthma
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要点】:该研究是一项随机对照试验,旨在探究通过减少屋尘螨过敏原和补充ω-3脂肪酸的饮食干预是否可以降低儿童哮喘和过敏的发生率,其创新点在于结合两种干预措施预防哮喘的随机对照试验设计。

方法】:研究将616名有哮喘家族史的高风险孕妇随机分为四组,分别接受安慰剂饮食干预无螨减少(A组)、安慰剂饮食干预有螨减少(B组)、活性饮食干预无螨减少(C组)和活性饮食干预有螨减少(D组),通过问卷调查、过敏原皮肤点刺试验、血液检测等方法收集数据。

实验】:数据收集从婴儿出生后每季度一次直至一岁,之后每半年一次直至五岁,实验中进行了盲评估,主要结局包括过敏致敏的发展和哮喘的存在及严重程度,研究使用的数据集未明确提及,但涉及婴儿床、卧室和游戏室地板的灰尘收集。