Protocol for an outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of atopic eczema in neonates, with an embedded mechanistic study: the Softened Water for Eczema Prevention (SOFTER) trial.
Protocol for an outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of atopic eczema in neonates, with an embedded mechanistic study: the Softened Water for Eczema Prevention (SOFTER) trial.
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用于预防新生儿特应性湿疹的离子交换水软化器的结果评估者盲态试点随机对照试验方案，其中包含一项嵌入式机制研究：软化水预防湿疹 (SOFTER) 试验。
DOI：
10.1136/bmjopen-2018-027168
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发表时间：
2019
期刊：
影响因子：
2.9
通讯作者：
Flohr,Car
中科院分区：
文献类型：
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作者：
Jabbar-Lopez,ZarifK;Gurung,Nikeeta;Greenblatt,Danielle;Briley,Annette;Chalmers,JoanneR;Thomas,KimSuzanne;Frost,Tony;Kezic,Sanja;Common,JohnEA;Kong,HeidiH;Segre,JulieA;Danby,Simon;Cork,MichaelJ;Peacock,JanetL;Flohr,Car
特应性湿疹影响20%的英国儿童，环境因素在其病因中起着重要作用。一些观察性研究表明，生活在硬水地区的儿童患特应性湿疹的风险增加。预防湿疹的软化水试点试验测试了在出生时左右安装国产离子交换水软化器的可行性，以降低有特应性家族史的儿童患特应性湿疹的风险。另一个目的是通过嵌入的机制研究来探索其病理生理学机制。方法和分析多中心平行分组评估者随机对照试验。参与者是新生儿(n=80)，生活在硬水(>；250 mg/L碳酸钙)地区，由于有特应性湿疹家族史，有患特应性湿疹的风险。参与者将在出生前按1：1的比例随机进行。干预组将在出生前安装离子交换水软化器。对照组将获得他们惯常的家庭硬水供应。随访期将持续到6个月大的 。数据将在出生时(基线)、1、3和6个月大时收集。主要结果是筛选出的愿意并能够随机选择的合格家庭的比例。还将评估几个次级可行性和临床终点，以及机械性结果。数据将在意向治疗的基础上进行分析。将不会对临床结果进行假设检验。研究的可接受性将通过半结构访谈进行评估。伦理和传播本研究已由西北-利物浦东部研究伦理委员会审查并给予好评(参考文献：17/NW/0661)。这项研究的结果将在国际会议和同行评议的科学期刊上公布。我们将向参与家庭发送试点试验结果的摘要。试验登记编号NCT03270566。
IntroductionAtopic eczema affects 20% of UK children, and environmental factors are important in its aetiology. Several observational studies suggest an increased risk of atopic eczema in children living in hard water areas. The Softened Water for Eczema Prevention pilot trial tests the feasibility of installing domestic ion-exchange water softeners around the time of birth to reduce the risk of atopic eczema in children with a family history of atopy. A further aim is to explore the pathophysiological mechanisms for this in an embedded mechanistic study.Methods and analysisMulticentre parallel group assessor-blinded randomised controlled pilot trial. Participants are newborn babies (n=80) living in a hard water (>250 mg/L calcium carbonate) area at risk of developing atopic eczema because of a family history of atopy. Participants will be randomised prior to birth in a 1:1 ratio. The intervention group will have an ion-exchange water softener installed prior to birth. The control group will receive their usual domestic hard water supply. Follow-up will be until 6 months of age. Data will be collected at birth (baseline), 1, 3 and 6 months of age. The main outcome is the proportion of eligible families screened who are willing and able to be randomised. Several secondary feasibility and clinical endpoints will also be evaluated, alongside mechanistic outcomes. Data will be analysed on an intention-to-treat basis. There will be no hypothesis testing for the clinical outcomes. Study acceptability will be evaluated through semistructured interviews.Ethics and disseminationThis study has been reviewed and given a favourable opinion by the North West–Liverpool East Research Ethics Committee (Ref: 17/NW/0661). The results of the study will be reported at international conferences and in peer-reviewed scientific journals. We will send participating families a summary of the pilot trial results.Trial registration numberNCT03270566.