School of Nursing, Midwifery and Social Work, The University of Manchester, Manchester, UK.
BMC Pediatr. 2011 May 13;11:35. doi: 10.1186/1471-2431-11-35.
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.
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.
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/m(2)/h to 11.7 g/m(2)/h; CP group 4 weeks: 10.9 g/m(2)/h to 13.3 g/m(2)/h; 8 weeks: 11.4 g/m(2)/h to 12.9 g/m(2)/h; W group 4 weeks:10.9 g/m(2)/h to 12.2 g/m(2)/h; 8 weeks: 11.4 g/m(2)/h to 12.9 g/m(2)/h.
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.
新生儿皮肤的脆弱性使其容易出现多种皮肤问题。尽管如此，目前仍然缺乏高质量的证据来指导实践。已发表的比较水和皮肤清洁剂的研究并未提供足够的数据来支持一项充分有力的试验。这些研究也没有区分是否有特应性皮炎倾向的婴儿。我们进行了一项试点研究，作为设计一项最佳试验的前奏，以调查使用特定清洁剂洗澡是否优于只用清水洗澡。目的是提供基线数据，为主要试验设计（即人群、主要结局、样本量计算）提供决策依据，并优化研究环境中的试验流程的稳健性。
100 名健康、足月的新生儿，年龄<24 小时，随机分为用清水和棉花（W）或清洁产品（CP）洗澡。提倡每周至少洗 3 次澡。根据家族特应性皮炎史对婴儿进行分层。在出生后 24 小时内和 4 周和 8 周后测量经表皮水分流失（TEWL）、角质层含水量和皮肤表面 pH 值。在大腿、前臂和腹部进行测量。女性还填写了问卷和日记，记录洗澡习惯和医疗治疗情况。
49 名婴儿被随机分配到清洁产品组，51 名婴儿被分配到清水组。每个时间点平均 TEWL 测量值的 95%置信区间（CI）为：全样本基线：10.8g/m(2)/h 至 11.7g/m(2)/h；CP 组 4 周：10.9g/m(2)/h 至 13.3g/m(2)/h；8 周：11.4g/m(2)/h 至 12.9g/m(2)/h；W 组 4 周：10.9g/m(2)/h 至 12.2g/m(2)/h；8 周：11.4g/m(2)/h 至 12.9g/m(2)/h。
这项试点研究提供了有价值的基线数据和重要的试验过程信息。例如，进行优势试验的决定与我们的数据不一致；因此，建议进行非劣效性试验。
