Effect on skin hydration of using baby wipes to clean the napkin area of newborn babies::assessor-blinded randomised controlled equivalence trial

摘要

BACKGROUND: Some national guidelines recommend the use of water alone for napkin cleansing. Yet, there is a readiness, amongst many parents, to use baby wipes.Evidence from randomised controlled trials, of the effect of baby wipes onnewborn skin integrity is lacking. We conducted a study to examine the hypothesisthat the use of a specifically formulated cleansing wipe on the napkin area ofnewborn infants (<1 month) has an equivalent effect on skin hydration whencompared with using cotton wool and water (usual care).METHODS: A prospective, assessor-blinded, randomised controlled equivalence trialwas conducted during 2010. Healthy, term babies (n=280), recruited within 48hours of birth, were randomly assigned to have their napkin area cleansed with analcohol-free baby wipe (140 babies) or cotton wool and water (140 babies).Primary outcome was change in hydration from within 48 hours of birth to 4 weeks post-birth. Secondary outcomes comprised changes in trans-epidermal water loss,skin surface pH and erythema, presence of microbial skin contaminants/irritantsat 4 weeks and napkin dermatitis reported by midwife at 4 weeks and mother duringthe 4 weeks.RESULTS: Complete hydration data were obtained for 254 (90.7 %) babies. Wipeswere shown to be equivalent to water and cotton wool in terms of skin hydration(intention-to-treat analysis: wipes 65.4 (SD 12.4) vs. water 63.5 (14.2), p=0.47,95% CI -2.5 to 4.2; per protocol analysis: wipes 64.6 (12.4) vs. water 63.6(14.3), p=0.53, 95% CI -2.4 to 4.2). No significant differences were found in thesecondary outcomes, except for maternal-reported napkin dermatitis, which washigher in the water group (p=0.025 for complete responses).CONCLUSIONS: Baby wipes had an equivalent effect on skin hydration when compared with cotton wool and water. We found no evidence of any adverse effects of using these wipes. These findings offer reassurance to parents who choose to use babywipes and to health professionals who support their use.TRIAL REGISTRATION: Current Controlled Trials ISRCTN86207019.