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

Price, Alan; Lythgoe, J; Ackers-Johnson, J; Cook, PA; Clarke-Cornwell, AM; MacVane Phipps, FE

Abstract

Background
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.
Methods
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 to 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.
Results
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%).
Conclusions
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.

Citation

Price, A., Lythgoe, J., Ackers-Johnson, J., Cook, P., Clarke-Cornwell, A., & MacVane Phipps, F. (2021). 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. Pediatrics and Neonatology, 62(2), 138-145. https://doi.org/10.1016/j.pedneo.2020.10.003

• Journal Article Type: Article
• Acceptance Date: Oct 19, 2020
• Online Publication Date: Oct 23, 2020
• Publication Date: Mar 1, 2021
• Deposit Date: Nov 19, 2020
• Publicly Available Date: Nov 19, 2020
• Journal: Pediatrics & Neonatology
• Print ISSN: 1875-9572
• Publisher: Elsevier
• Volume: 62
• Issue: 2
• Pages: 138-145
• DOI: https://doi.org/10.1016/j.pedneo.2020.10.003
• Publisher URL: https://doi.org/10.1016/j.pedneo.2020.10.003
• Related Public URLs: https://www.journals.elsevier.com/pediatrics-and-neonatology/