Duke Primary Care Research Consortium, Duke University, Durham, NC, USA.
Oregon Rural Practice-based Research Network, Oregon Health & Science University, Portland, OR, USA.
Trials. 2020 Mar 4;21(1):243. doi: 10.1186/s13063-020-4150-5.
Atopic dermatitis (AD) is a common, chronic skin disorder often beginning in infancy. Skin barrier dysfunction early in life serves as a central event in the pathogenesis of AD. In infants at high risk of developing AD, preventative application of lipid-rich emollients may reduce the risk of developing AD. This study aims to measure the effectiveness of this intervention in a population not selected for risk via a pragmatic, randomized, physician-blinded trial in the primary care setting.
Infant-parent dyads are recruited from a primary care practice participating through one of four practice-based research networks in Oregon, Colorado, Wisconsin, and North Carolina. Eligible dyads are randomized to the intervention (daily use of lipid-rich emollient) or the control (no emollient) group (n = 625 infants in each) and are followed for 24 months. The primary outcome is the cumulative incidence of physician-diagnosed AD and secondary outcomes include caregiver-reported measures of AD and development of other atopic diseases. Data collection occurs via chart review and surveys, with no study visits required. Data will be analyzed utilizing intention-to-treat principles.
AD is a common skin condition in infants that affects quality of life and is associated with the development of other atopic diseases. If a safe intervention, such as application of lipid-rich emollients, in the general population effectively decreases AD prevalence, this could alter the guidance given by providers regarding routine skin care of infants. Because of the pragmatic design, we anticipate that this trial will yield generalizable results.
ClinicalTrials.gov: NCT03409367. Registered on 11 February 2018.
特应性皮炎（AD）是一种常见的慢性皮肤疾病，通常在婴儿期开始。生命早期的皮肤屏障功能障碍是 AD 发病机制中的一个中心事件。在有发生 AD 高风险的婴儿中，预防性使用富含脂质的保湿剂可能会降低发生 AD 的风险。本研究旨在通过在初级保健环境中进行一项实用的、随机的、医生盲法试验，在未选择风险的人群中测量这种干预的效果。
从参与俄勒冈州、科罗拉多州、威斯康星州和北卡罗来纳州四个基于实践的研究网络之一的初级保健实践中招募婴儿-父母二人组。合格的二人组被随机分配到干预（每天使用富含脂质的保湿剂）或对照组（不使用保湿剂）（每组 625 名婴儿），并随访 24 个月。主要结局是医生诊断的 AD 的累积发病率，次要结局包括照顾者报告的 AD 措施和其他特应性疾病的发展。数据收集通过图表审查和调查进行，不需要研究访问。数据将根据意向治疗原则进行分析。
AD 是一种常见的婴儿皮肤疾病，会影响生活质量，并与其他特应性疾病的发展有关。如果在普通人群中使用安全的干预措施，如应用富含脂质的保湿剂，能有效降低 AD 的患病率，这可能会改变提供者关于婴儿常规皮肤护理的指导。由于采用了实用的设计，我们预计该试验将产生可推广的结果。
ClinicalTrials.gov：NCT03409367。于 2018 年 2 月 11 日注册。
