The BaSICS (Baby Skin Integrity Comparison Survey) study : a prospective experimental study using maternal observations to report the effect of baby wipes on the incidence of irritant diaper dermatitis in infants, from birth to eight weeks of age

BackgroundBaby wipes have been shown to be safe and effective in maintaining skinintegrity when compared to the use of water alone. However, no previous studyhas compared different formulations of wipe. The aim of the BaSICS study was toidentify any differences in incidence of irritant diaper dermatitis (IDD) in infantsassigned to three different brands of wipe, all marketed as suitable for neonates,but which contained varying numbers of ingredients.MethodsWomen were recruited during the prenatal period. Participants were randomlyassigned to receive one of three brands of wipe for use during the first eightweeks following childbirth. All participants received the same nappies.Participants reported their infant’s skin integrity on a scale of 1 to 5 daily using abespoke smartphone application. Analysis of effect of brand on clinicallysignificant IDD (score 3 or more) incidence was conducted using a negativebinomial generalised linear model, controlling for possible confounders atbaseline. Analysts were blind to brand of wipe.ResultsOf 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 atsome point during the study. Mothers using the brand with the fewestingredients reported fewer days of clinically significant nappy rash (score≥3)than participants using the two other brands (p=0.002 and p