Allergy and Lung Health Unit, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.
BMJ Open. 2019 Mar 13;9(3):e024594. doi: 10.1136/bmjopen-2018-024594.
The skin is an important barrier against environmental allergens, but infants have relatively impaired skin barrier function. There is evidence that impaired skin barrier function increases the risk of allergic sensitisation, atopic dermatitis (AD) and food allergy. We hypothesise that regular prophylactic use of emollients, particularly those that are designed to improve skin barrier structure and function, will help prevent these conditions. With the aim of determining if application of a ceramide-dominant emollient two times per day reduces the risk of AD and food allergy, we have commenced a multicentre phase III, outcome assessor blinded, randomised controlled trial of this emollient applied from birth to 6 months.
Infants (n=760) with a family history of allergic disease will be recruited from maternity hospitals in Melbourne. The primary outcomes are as follows: the presence of AD, assessed using the UK Working Party criteria, and food allergy using food challenge, in the first 12 months of life as assessed by a blinded study outcome assessor. Secondary outcomes are as follows: food sensitisation (skin prick test), skin barrier function, AD severity, the presence of new onset AD after treatment cessation (between 6 and 12 months) and the presence of parent reported AD/eczema. Recruitment commenced in March 2018.
The PEBBLES Study is approved by the Human Research Ethics Committees of the Royal Children's Hospital (RCH) (#37090A) and the Mercy Hospital for Women (2018-008). Parents or guardians will provide written informed consent. Outcomes will be disseminated through peer-reviewed publications and presented at scientific conferences.
ACTRN12617001380381 and NCT03667651.
皮肤是抵御环境过敏原的重要屏障，但婴儿的皮肤屏障功能相对较弱。有证据表明，皮肤屏障功能受损会增加过敏致敏、特应性皮炎（AD）和食物过敏的风险。我们假设定期预防性使用保湿剂，特别是那些旨在改善皮肤屏障结构和功能的保湿剂，将有助于预防这些疾病。为了确定每天两次使用含有神经酰胺的保湿剂是否可以降低 AD 和食物过敏的风险，我们已经开始了一项多中心 III 期、评估者盲法、随机对照试验，该试验从出生到 6 个月期间使用这种保湿剂。
将从墨尔本的妇产医院招募具有过敏病史的婴儿（n=760）。主要结局如下：在生命的头 12 个月内，使用英国工作组标准评估 AD 的存在，并使用食物挑战评估食物过敏，由盲法研究结局评估者评估。次要结局如下：食物致敏（皮肤点刺试验）、皮肤屏障功能、AD 严重程度、治疗停止后（6-12 个月）新发 AD 的存在以及父母报告的 AD/湿疹的存在。招募工作于 2018 年 3 月开始。
PEBBLES 研究已获得皇家儿童医院（RCH）（#37090A）和慈悲医院妇女分院（2018-008）的人体伦理委员会的批准。父母或监护人将提供书面知情同意书。研究结果将通过同行评议的出版物进行传播，并在科学会议上进行报告。
ACTRN12617001380381 和 NCT03667651。
