Cooke 2015.

Study characteristics
Methods	Study design: pilot, assessor‐blinded RCT Study data collected: between September 2013 and July 2014  Treatment arms: 3 AD follow‐up: 4 weeks
Participants	Randomised: N = 115 (olive oil n = 38, sunflower oil n = 38, no oil n = 39) Inclusion criteria: participants with or without a family history of AE  Exclusion criteria: Mother 16 years of age or younger or without capacity to consent Admittance to Special Care Baby Unit Receiving phototherapy treatment Participation in another clinical trial Medical history preventing participation to endpoint Limb defects Non‐traumatic impairment of epidermal integrity Evidence of skin disorder at first assessment
Interventions	Intervention: randomization took place within 72 hours of birth, parents were instructed from the day after initial assessment to apply 4 drops of oil to their baby's left forearm, left thigh, and abdomen, twice a day. Parents in all groups were asked not to use any other skin care products at the 3 study sites; water only was advocated. Intervention period was 4 weeks Group 1: olive oil Group 2: sunflower oil  Comparator: the control group was provided no oil and was asked not to use any other skin care products at the 3 study sites; water only was advocated
Outcomes	Primary outcome: the change in structure of the lipid lamellae, a determinant of SC permeability (measured using ATR‐FTIR spectroscopy) and TEWL (measured via Biox Aquaflux Model AF200) Secondary outcome: stratum corneum hydration (measured via a Corneometer® Model CM825); skin surface pH (measured by skin pH meter® Model PH 905); clinical observations around changes in the skin using a modified Neonatal Skin Condition Score; and erythema (measured by a Mexameter® Model MX18 probe)  Adverse effects: adverse events, including skin infections, skin reactions, and serious adverse events, were prompted for and collected for all participants
Identification	Country: England, UK Setting: St. Mary's Hospital, Manchester Sponsorship source: AC was funded by the NIHR, and this paper was independent research arising from the Doctoral Research Fellowship, supported by NIHR
Declarations of interest	None reported
Notes