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首页> 外文期刊>BMC Pediatrics >Infant skin-cleansing product versus water: A pilot randomized, assessor-blinded controlled trial
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Infant skin-cleansing product versus water: A pilot randomized, assessor-blinded controlled trial

机译：婴儿皮肤清洁产品与水的对比：一项先导者随机，评估者双盲对照试验

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Background The vulnerability of newborn babies' skin creates the potential for a number of skin problems. Despite this, there remains a dearth of good quality evidence to inform practice. Published studies comparing water with a skin-cleansing product have not provided adequate data to inform an adequately powered trial. Nor have they distinguished between babies with and without a predisposition to atopic eczema. We conducted a pilot study as a prequel to designing an optimum trial to investigate whether bathing with a specific cleansing product is superior to bathing with water alone. The aims were to produce baseline data which would inform decisions for the main trial design (i.e. population, primary outcome, sample size calculation) and to optimize the robustness of trial processes within the study setting. Methods 100 healthy, full term neonates aged <24 hours were randomly assigned to bathing with water and cotton wool (W) or with a cleaning product (CP). A minimum of bathing 3 times per week was advocated. Groups were stratified according to family history of atopic eczema. Transepidermal water loss (TEWL), stratum corneum hydration and skin surface pH were measured within 24 hours of birth and at 4 and 8 weeks post birth. Measurements were taken on the thigh, forearm and abdomen. Women also completed questionnaires and diaries to record bathing practices and medical treatments. Results Forty nine babies were randomized to cleansing product, 51 to water. The 95% confidence intervals (CI) for the average TEWL measurement at each time point were: whole sample at baseline: 10.8 g/m2/h to 11.7 g/m2/h; CP group 4 weeks: 10.9 g/m2/h to 13.3 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h; W group 4 weeks:10.9 g/m2/h to 12.2 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h. Conclusion This pilot study provided valuable baseline data and important information on trial processes. The decision to proceed with a superiority trial, for example, was inconsistent with our data; therefore a non-inferiority trial is recommended. Trial registration ISRCTN72285670
机译：背景技术新生婴儿皮肤的脆弱性可能引发许多皮肤问题。尽管如此，仍然缺乏高质量的证据来指导实践。将水与皮肤清洁产品进行比较的已发表研究尚未提供足够的数据来提供足够的动力试验。他们也没有区分患有特应性湿疹和没有特应性湿疹的婴儿。我们进行了一项前期研究，作为设计最佳试验的前传，以研究使用特定清洁产品沐浴是否优于仅用水沐浴。目的是产生基线数据，这些数据可为主要试验设计提供决策依据（即人群，主要结果，样本量计算），并优化研究环境中试验过程的稳健性。方法将100名24岁以下的健康足月新生儿随机分配用水和棉绒（W）或清洁产品（CP）进行沐浴。提倡每周最少洗澡3次。根据特应性湿疹的家族史将各组分层。在出生后24小时内以及出生后4周和8周，测量经皮水分损失（TEWL），角质层水合和皮肤表面pH值。在大腿，前臂和腹部进行测量。妇女还填写了调查表和日记，以记录沐浴习惯和医疗情况。结果将49名婴儿随机分配给清洁产品，其中51名婴儿分配给水。每个时间点的平均TEWL测量值的95％置信区间（CI）为：基线处的整个样品：10.8 g / m2 / h至11.7 g / m2 / h; CP组4周：10.9 g / m2 / h至13.3 g / m2 / h; 8周：11.4 g / m2 / h至12.9 g / m2 / h; W组4周：10.9 g / m2 / h至12.2 g / m2 / h; 8周：11.4克/平方米/小时至12.9克/平方米/小时。结论这项初步研究提供了有价值的基线数据和有关试验过程的重要信息。例如，进行优越性试验的决定与我们的数据不一致;因此，建议进行非自卑感试验。试用注册ISRCTN72285670

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