School of Health & Society, University of Salford, United Kingdom.
School of Health & Society, University of Salford, United Kingdom.
Pediatr Neonatol. 2021 Mar;62(2):138-145. doi: 10.1016/j.pedneo.2020.10.003. Epub 2020 Oct 23.
Baby wipes have been shown to be safe and effective in maintaining skin integrity when compared to the use of water alone. However, no previous study has compared different formulations of wipe. The aim of the BaSICS study was to identify any differences in incidence of irritant diaper dermatitis (IDD) in infants assigned to three different brands of wipe, all marketed as suitable for neonates, but which contained varying numbers of ingredients.
Women were recruited during the prenatal period. Participants were randomly assigned to receive one of three brands of wipe for use during the first eight weeks following childbirth. All participants received the same nappies. Participants reported their infant's skin integrity on a scale of 1-5 daily using a bespoke smartphone application. Analysis of effect of brand on clinically significant IDD (score 3 or more) incidence was conducted using a negative binomial generalised linear model, controlling for possible confounders at baseline. Analysts were blind to brand of wipe.
Of 737 women enrolled, 15 were excluded (admitted to neonatal intensive care, premature or other infant health issues). Of the 722 eligible babies, 698 (97%) remained in the study for the full 8-week duration, 24.6% of whom had IDD at some point during the study. Mothers using the brand with the fewest ingredients reported fewer days of clinically significant nappy rash (score≥3) than participants using the two other brands (p = 0.002 and p < 0.001). Severe IDD (grades 4 and 5) was rare (2.4%).
Rarity of severe IDD suggested that sensitive formula baby wipes are safe when used in cleansing babies from birth to eight weeks during nappy changes. The brand with fewest ingredients had significantly fewer days of clinically significant IDD. Daily observations recorded on a smartphone application proved to be a highly acceptable method of obtaining real-time data on IDD.
This study was not designed or registered as a clinical trial as no intervention in normal patterns of infant care took place. Mothers who had already decided to use disposable nappies and a baby wipe product agreed to observe and report on their infants' skin condition; in return they received a 9-week supply of free nappies and wipes.
与单独使用水相比，婴儿湿巾在维持皮肤完整性方面已被证明是安全且有效的。但是，以前没有研究比较过不同配方的湿巾。BaSICS 研究的目的是确定分配给三种不同品牌的湿巾的婴儿刺激性尿布皮炎（IDD）发生率是否存在差异，这三种品牌的湿巾均被宣传为适合新生儿，但所含成分数量不同。
在产前阶段招募了女性。参与者被随机分配接受三种品牌的湿巾中的一种，用于分娩后头 8 周。所有参与者都使用相同的尿布。参与者使用定制的智能手机应用程序每天对婴儿的皮肤完整性进行 1-5 分制评分。使用负二项广义线性模型分析品牌对临床显著 IDD（评分 3 或更高）发生率的影响，同时控制基线时的可能混杂因素。分析人员对湿巾的品牌不知情。
在纳入的 737 名女性中，有 15 名被排除（入住新生儿重症监护病房，早产或其他婴儿健康问题）。在 722 名合格的婴儿中，有 698 名（97%）在整个 8 周研究期间仍留在研究中，其中 24.6%的婴儿在研究过程中的某个时候患有 IDD。使用成分最少的品牌的母亲报告的临床显著尿布疹（评分≥3）天数少于使用其他两个品牌的母亲（p=0.002 和 p<0.001）。严重 IDD（等级 4 和 5）很少见（2.4%）。
严重 IDD 的罕见性表明，在更换尿布期间，从出生到 8 周使用敏感配方的婴儿湿巾清洁婴儿是安全的。成分最少的品牌的临床显著 IDD 天数明显减少。使用智能手机应用程序记录的日常观察结果证明是一种非常可行的方法，可以实时获取 IDD 数据。
本研究不是按照临床试验设计或注册的，因为在正常的婴儿护理模式中没有进行干预。已经决定使用一次性尿布和婴儿湿巾产品的母亲同意观察并报告其婴儿的皮肤状况；作为回报，他们收到了 9 周的免费尿布和湿巾供应。
