Lavender 2013.

Study characteristics
Methods	Study design: assessor‐blinded, randomised, controlled, non‐inferiority trial Recruitment date: between February 2010 and March 2011 Treatment arms: 2 AD follow‐up: 2 weeks and 4 weeks for AD
Participants	Randomised: N = 307 (wash product n = 159; bathing with water alone n = 148) Inclusion criteria:  Newborn infants born at 37 weeks' gestation or later  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 Infant going for adoption
Interventions	Bathing regimen using a newborn wash product or water alone before the first bath. Participating mothers were instructed to bathe their neonate at least 3 times per week and to avoid rubbing the skin. On the day of assessment, mothers were requested to delay bathing their neonate until measurements had been taken Intervention: those allocated to the wash product (experimental) were provided with sufficient newborn wash and were advised to dilute the product at a ratio of 3 squirts per bath Comparator: control group used water alone; parents were not provided with any products. If these mothers wished to use shampoo on their neonates’ hair, they were requested to do this outside of the bath, and to ensure that the neonate’s body was wrapped in a towel to prevent contact with the skin  Cleanser: Johnson’s Baby Top‐To‐Toe Bath (Johnson & Johnson Limited, Maidenhead SL6 3UG, UK) is a soap‐free liquid cleanser designed for newborns’ skin. It is sodium lauryl sulphate‐free and consists of a proprietary blend of non‐ionic and amphoteric surfactants that when combined result in large micelles that clean via dispersal of fats without disrupting the skin barrier. The formula contains well‐tolerated preservatives and a low level of fragrance; it is pH‐adjusted (around 5.5) and hypoallergenic. The International Nomenclature Cosmetic Ingredients list comprised aqua, coco glucoside, coca midopropyl betaine, citric acid, acrylates/C10‐30 alkyl acrylate crosspolymer, sodium chloride, glyceryl oleate, p‐Anisic acid, sodium hydroxide, phenoxyethanol, sodium benzoate, and parfum
Outcomes	Primary outcomes: the average of TEWL measurements, using a closed chamber system, over 3 sites (outer forearm, midpoint between wrist and elbow; front of thigh, midpoint between knee and groin; abdomen, midpoint between umbilicus and sternum) at 14 days following birth using AquaFlux Model AF200 (Biox Systems Ltd, London, UK) Secondary outcomes: TEWL at 4 weeks post birth, skin surface pH using Courage + Khazaka Skin‐pH‐MeterR PH 900, and stratum corneum hydration scores using CorneometerR CM 820 (Courage + Khazaka Electronic GmbH, Cologne, Germany) from baseline (within 48 hours of birth). Because of the sensitivity of the neonate’s skin in the early weeks following birth, this is an ideal time to investigate the effects of wash products. Any differences in these outcomes are likely to be greater than later in an infant’s life, when the skin barrier is more stable Adverse events: not reported
Identification	Country: UK Setting: teaching hospital in the North West of England Sponsorship source: funded by Johnson & Johnson Consumer Companies, Inc.
Declarations of interest	None reported
Notes