Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK.
Centre for Genomic and Experimental Medicine, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK.
Health Technol Assess. 2024 Jul;28(29):1-116. doi: 10.3310/RHDN9613.
Atopic eczema is a common childhood skin problem linked with asthma, food allergy and allergic rhinitis that impairs quality of life.
To determine whether advising parents to apply daily emollients in the first year can prevent eczema and/or other atopic diseases in high-risk children.
A United Kingdom, multicentre, pragmatic, two-arm, parallel-group randomised controlled prevention trial with follow-up to 5 years.
Twelve secondary and four primary care centres.
Healthy infants (at least 37 weeks' gestation) at high risk of developing eczema, screened and consented during the third trimester or post delivery.
Infants were randomised (1 : 1) within 21 days of birth to apply emollient (Doublebase Gel®; Dermal Laboratories Ltd, Hitchin, UK or Diprobase Cream®) daily to the whole body (excluding scalp) for the first year, plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). Families were not blinded to allocation.
Primary outcome was eczema diagnosis in the last year at age 2 years, as defined by the UK Working Party refinement of the Hanifin and Rajka diagnostic criteria, assessed by research nurses blinded to allocation. Secondary outcomes up to age 2 years included other eczema definitions, time to onset and severity of eczema, allergic rhinitis, wheezing, allergic sensitisation, food allergy, safety (skin infections and slippages) and cost-effectiveness.
One thousand three hundred and ninety-four newborns were randomised between November 2014 and November 2016; 693 emollient and 701 control. Adherence in the emollient group was 88% (466/532), 82% (427/519) and 74% (375/506) at 3, 6 and 12 months. At 2 years, eczema was present in 139/598 (23%) in the emollient group and 150/612 (25%) in controls (adjusted relative risk 0.95, 95% confidence interval 0.78 to 1.16; = 0.61 and adjusted risk difference -1.2%, 95% confidence interval -5.9% to 3.6%). Other eczema definitions supported the primary analysis. Food allergy (milk, egg, peanut) was present in 41/547 (7.5%) in the emollient group versus 29/568 (5.1%) in controls (adjusted relative risk 1.47, 95% confidence interval 0.93 to 2.33). Mean number of skin infections per child in the first year was 0.23 (standard deviation 0.68) in the emollient group versus 0.15 (standard deviation 0.46) in controls; adjusted incidence rate ratio 1.55, 95% confidence interval 1.15 to 2.09. The adjusted incremental cost per percentage decrease in risk of eczema at 2 years was £5337 (£7281 unadjusted). No difference between the groups in eczema or other atopic diseases was observed during follow-up to age 5 years via parental questionnaires.
Two emollient types were used which could have had different effects. The median time for starting emollients was 11 days after birth. Some contamination occurred in the control group (< 20%). Participating families were unblinded and reported on some outcomes.
We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children. Emollient use was associated with a higher risk of skin infections and a possible increase in food allergy. Emollient use is unlikely to be considered cost-effective in this context.
To pool similar studies in an individual patient data meta-analysis.
This trial is registered as ISRCTN21528841.
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/67/12) and is published in full in ; Vol. 28, No. 29. See the NIHR Funding and Awards website for further award information.
特应性皮炎是一种常见的儿童期皮肤问题，与哮喘、食物过敏和过敏性鼻炎有关，会降低生活质量。
确定在高危儿童中，建议父母在第一年每天使用保湿剂是否可以预防特应性皮炎和/或其他特应性疾病。
英国的一项多中心、实用、双臂、平行组随机对照预防试验，随访至 5 年。
12 个二级和 4 个初级保健中心。
在妊娠晚期（至少 37 周）筛选并同意参加的健康婴儿（高风险发展为特应性皮炎）。
婴儿在出生后 21 天内随机分配（1:1），每天在整个身体（不包括头皮）上使用保湿剂（Doublebase Gel®；Dermal Laboratories Ltd，Hitchin，英国或 Diprobase Cream®），第一年进行标准皮肤护理（保湿剂组）或仅进行标准皮肤护理（对照组）。家庭没有被蒙蔽分配。
主要结果是在 2 岁时根据英国工作组对 Hanifin 和 Rajka 诊断标准的细化定义诊断为湿疹，由对分配情况不知情的研究护士评估。至 2 岁的次要结果包括其他湿疹定义、发病时间和严重程度、过敏性鼻炎、喘息、过敏致敏、食物过敏、安全性（皮肤感染和滑脱）和成本效益。
2014 年 11 月至 2016 年 11 月间共招募了 1394 名新生儿；693 名接受保湿剂，701 名接受对照。在保湿剂组中，3、6 和 12 个月时的依从率分别为 88%（466/532）、82%（427/519）和 74%（375/506）。在 2 岁时，保湿剂组中 139/598（23%）患有湿疹，对照组中 150/612（25%）患有湿疹（调整后的相对风险 0.95，95%置信区间 0.78 至 1.16； = 0.61，调整后的风险差异-1.2%，95%置信区间-5.9%至 3.6%）。其他湿疹定义支持主要分析。在保湿剂组中，有 41/547（7.5%）的儿童患有食物过敏（牛奶、鸡蛋、花生），而对照组中为 29/568（5.1%）（调整后的相对风险 1.47，95%置信区间 0.93 至 2.33）。在第一年中，每个孩子的皮肤感染平均数量为 0.23（标准差 0.68），在保湿剂组中为 0.15（标准差 0.46），调整后的发病率比为 1.55，95%置信区间 1.15 至 2.09。调整后每降低 2 岁时湿疹风险的百分比的成本为 5337 英镑（未调整的 7281 英镑）。在 5 岁的随访期间，通过父母问卷调查，没有观察到两组在湿疹或其他特应性疾病方面的差异。
使用了两种保湿剂，可能有不同的效果。开始使用保湿剂的中位数时间为出生后 11 天。对照组中存在小于 20%的交叉污染。参与家庭未被蒙蔽，并报告了一些结果。
我们没有发现生命第一年每天使用保湿剂可以预防高危儿童的特应性皮炎。保湿剂的使用与皮肤感染风险增加有关，并且可能与食物过敏增加有关。在这种情况下，保湿剂的使用不太可能被认为具有成本效益。
在个体患者数据荟萃分析中汇集类似的研究。
本试验由英国国家卫生与保健研究所（NIHR）卫生技术评估计划（NIHR 奖励号：12/67/12）资助，并在 ; 第 28 卷，第 29 期全文发表。有关进一步的奖励信息，请访问 NIHR 资助和奖励网站。
