Emollients to Prevent Pediatric Eczema: A Randomized Clinical Trial.

IF 11 1区 医学 Q1 DERMATOLOGY
Eric L Simpson, LeAnn C Michaels, Katrina Ramsey, Lyle J Fagnan, Donald E Nease, Mary Henningfield, Rowena J Dolor, Jodi Lapidus, Xaviera Martinez-Ziegenfuss, Annette Vu, Laura Ferrara, Katharine E Zuckerman, Cynthia D Morris, Hywel C Williams
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引用次数: 0

Abstract

Importance: Atopic dermatitis (AD) imposes a global health burden for children and is a risk factor for developing food allergy and asthma. Few studies have evaluated emollient intervention for primary AD prevention in infants not selected for risk.

Objective: To determine whether emollient intervention in infants not selected for risk reduces AD incidence by age 24 months.

Design, setting, and participants: A randomized, decentralized pragmatic clinical trial was conducted that involving 1247 infant-parent dyads recruited from 25 community-based pediatric and family medicine clinics that are members of 4 statewide practice-based research networks. Participants were recruited from July 2018 to February 2021, with follow-up completed through February 2023.

Intervention: Dyads were randomized to 1 of 2 groups: a daily full-body emollient application daily moisturizer group starting by age 9 weeks or a control group that refrained from emollient use.

Main outcomes and measures: The primary outcome was physician-diagnosed AD recorded in the patient's medical record by age 24 months. Participants completed quarterly electronic surveys to report adverse events and alert the team if an AD diagnosis had been made. Trained research coordinators abstracted participants' medical records.

Results: Of 1247 infants, 553 (44.3%) were female, and the mean (SD) age at randomization was 23.9 (16.3) days. At 24 months, the cumulative incidence of AD was 36.1% (SE, 2.1) in the daily moisturizer group and 43.0% (SE 2.1) in the control group, with a relative risk (RR) of 0.84 (95% CI, 0.73-0.97; P = .02), and the magnitude of effect was larger in the population not at high risk of AD (RR, 0.75; 95% CI, 0.60-0.90; P = .01). The protective effect was significantly modified by the presence of a dog in the home (RR, 0.68; 95% CI, 0.50-0.90; P = .01). There were no between-group differences in cutaneous adverse events.

Conclusions and relevance: This randomized clinical trial found that daily emollient application beginning before age 9 weeks in a representative US population not selected for risk reduced the cumulative incidence of AD at age 24 months. Implementing this approach to pediatric skin care may be a feasible way to reduce the burden of AD in US communities.

Trial registration: ClinicalTrials.gov Identifier: NCT03409367.

润肤剂预防儿童湿疹:一项随机临床试验。
重要性:特应性皮炎(AD)对儿童造成了全球性的健康负担,是发生食物过敏和哮喘的危险因素。很少有研究对未选择风险的婴儿进行软性干预以预防原发性AD。目的:确定对未被选为高危的婴儿进行软性干预是否能降低24月龄时AD的发病率。设计、设置和参与者:进行了一项随机、分散的实用临床试验,从25个社区儿科和家庭医学诊所招募了1247对婴儿父母,这些诊所是4个全州实践研究网络的成员。参与者于2018年7月至2021年2月招募,随访至2023年2月。干预:将二人随机分为两组中的一组:从9周龄开始每天涂抹全身润肤霜的组,或不使用润肤霜的对照组。主要结局和措施:主要结局是医生诊断的AD记录在患者24个月的医疗记录中。参与者完成了季度电子调查,报告不良事件,并在做出AD诊断时通知团队。训练有素的研究协调员提取了参与者的医疗记录。结果:1247例婴儿中,553例(44.3%)为女婴,随机分组时的平均(SD)年龄为23.9(16.3)天。24个月时,每日保湿霜组AD的累积发病率为36.1% (SE, 2.1),对照组为43.0% (SE, 2.1),相对危险度(RR)为0.84 (95% CI, 0.73-0.97;P = 0.02),非AD高危人群的影响幅度更大(RR, 0.75;95% ci, 0.60-0.90;p = 0.01)。家中有狗的存在显著改变了这种保护作用(RR, 0.68;95% ci, 0.50-0.90;p = 0.01)。皮肤不良事件组间无差异。结论和相关性:这项随机临床试验发现,在9周龄前开始每日涂抹润肤剂,在未选择风险的代表性美国人群中,可降低24月龄时AD的累积发病率。在儿童皮肤护理中实施这种方法可能是减轻美国社区AD负担的可行方法。试验注册:ClinicalTrials.gov标识符:NCT03409367。
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来源期刊
JAMA dermatology
JAMA dermatology DERMATOLOGY-
CiteScore
14.10
自引率
5.50%
发文量
300
期刊介绍: JAMA Dermatology is an international peer-reviewed journal that has been in continuous publication since 1882. It began publication by the American Medical Association in 1920 as Archives of Dermatology and Syphilology. The journal publishes material that helps in the development and testing of the effectiveness of diagnosis and treatment in medical and surgical dermatology, pediatric and geriatric dermatology, and oncologic and aesthetic dermatologic surgery. JAMA Dermatology is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications. It is published online weekly, every Wednesday, and in 12 print/online issues a year. The mission of the journal is to elevate the art and science of health and diseases of skin, hair, nails, and mucous membranes, and their treatment, with the aim of enabling dermatologists to deliver evidence-based, high-value medical and surgical dermatologic care. The journal publishes a broad range of innovative studies and trials that shift research and clinical practice paradigms, expand the understanding of the burden of dermatologic diseases and key outcomes, improve the practice of dermatology, and ensure equitable care to all patients. It also features research and opinion examining ethical, moral, socioeconomic, educational, and political issues relevant to dermatologists, aiming to enable ongoing improvement to the workforce, scope of practice, and the training of future dermatologists. JAMA Dermatology aims to be a leader in developing initiatives to improve diversity, equity, and inclusion within the specialty and within dermatology medical publishing.
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