Lavender 2012.

Study characteristics
Methods	Study design: prospective, assessor‐blinded, randomised, controlled trial  Recruitment date: February and October 2010 Treatment arms: 2 AD follow‐up: 4 weeks
Participants	Randomised: N = 280 (napkin area cleansed with an alcohol‐free baby wipe n = 140 babies; cotton wool and water n = 140 babies) Inclusion criteria:  Infants born at 37 weeks' gestation or later and using disposable nappies Exclusion criteria: Admitted to the neonatal unit Receiving phototherapy Limb defects Non‐traumatic impairment of epidermal integrity Evidence of skin disorder at first visit Chromosomal abnormality or other syndromic diagnosis Baby going for adoption
Interventions	Intervention: napkin cleansing regimen using a specific type of baby wipe. Participating mothers were given a cleansing demonstration by a healthcare assistant. All mothers were advised to use nappies that were supplied by researchers for the duration of the study to ensure similar absorbency ‐ a factor likely to influence skin hydration. Mothers were also advised to avoid using napkin cream, other than that supplied by the research team as a rescue treatment. Parents were provided with cotton wool or baby wipes, according to their allocated trial arm Comparator: napkin cleansing regimen using cotton wool and water Wipe and emollient: Johnson's Baby Skincare Fragrance Free Wipe (Johnson & Johnson Ltd., Maidenhead SL6 3UG, UK). The emollients contained glycerin and glyceryl oleate. The baby wipes also contained citric acid, which can have dual functionality as pH adjuster and chelator. Additionally, it was important to have a wipe with a pH close to the skin pH (around 4.9 in this case); if the pH is too low, this could be an irritant; if too high, this would increase protease activity and inhibit lipid lamellar synthesis in the skin barrier. Wipes contained 97% water and were free of alcohol, fragrance, essential oils, soap, and other harsh detergents; they were appropriately preserved to prevent growth of micro‐organisms. Cloth material of the wipes was a rayon viscose and polyester non‐woven fibre blend, entangled in a matrix of trough water jets without chemical binders. This is designed to reduce friction when wiped across the skin surface
Outcomes	Primary outcome: change in stratum corneum hydration scores on the buttocks from first assessment (within 48 hours of birth) to 4 weeks post birth, using a Corneometer Secondary outcomes: change in erythema measurements using a Mexameter (W MX 18) (27); change in transepidermal water loss (TEWL) using an Aquaflux (AF200) (28); change in skin surface pH (using a pH meter). Measurements were taken on the babies’ buttocks at first assessment (within 48 hours of birth) and 4 weeks post birth Adverse effects: study group found no evidence of any adverse effects of using these wipes
Identification	Country: UK Setting: North West of England
Declarations of interest	None reported
Notes