McClanahan 2019.

Study characteristics
Methods	Study design: single‐centred, investigator‐blinded RCT Recruitment dates: June 2011 and January 2014  Treatment arms: 2 AD follow‐up: study visits occurred at 2, 6, and 12 months. Two phone calls were performed at 18 to 24 months to discuss development of AD, provide education on emollient use, and supply additional product
Participants	Randomisation: N = 100 (intervention n = 54, control n = 46) Inclusion criteria: Parent/guardian over 18 years of age Newborn within 21 days considered at high risk for AD development (first‐degree relative with history of AD, asthma, or allergic rhinitis) Parents/guardians of participants willing to comply with study procedures Exclusion criteria:  Premature newborn (born before 37 weeks' gestational age) Diagnosed with major congenital anomaly Significant dermatitis at birth (excluding seborrhoeic dermatitis) Immunodeficiency disorder Serious medical problem making emollient use inadvisable by increasing the risk of adverse events or inhibiting outcomes assessment
Interventions	Intervention group: instructed to apply moisturiser daily to all body surfaces excluding the scalp and diaper area and to use the cleanser only as needed during bathing Comparator: control group was given no specific instructions regarding use of emollients except to use emollients of their choice on an as needed basis Moisturiser/Emollient: Cetaphil Restoraderm (Galderma, Baie d’Urfé, Montreal, Canada); key ingredients include shea butter as a lipid source, pseudoceramide‐5, and 2 FLG breakdown products. A cleanser was also provided. No bathing frequency instructions were provided. Both products were to be used within 21 days of birth
Outcomes	Primary outcomes: cumulative incidence of AD at 12 months diagnosed by a blinded investigator (‘investigator‐confirmed AD’). UK Working Party Criteria adapted to identify incident cases of AD were used rather than a 12‐month period of prevalence  Secondary outcomes: a post‐hoc secondary analysis of the primary outcome was also performed: cumulative incidence of AD defined as AD diagnosed by an investigator and/or an outside paediatrician or chart review within 12 or 24 months (any AD) Adverse events: intervention group vs control group: bacterial skin infections (7.4% vs 6.5%); hypersensitivity reactions including irritant contact dermatitis and urticaria (14.8% vs 8.7%). No serious adverse events were reported in either group
Identification	Country: Oregon, USA Setting: maternal hospital wards Sponsorship source: all funding sources supported the work
Declarations of interest	Dr. Simpson has received consulting fees from Galderma, which supplied emollient for this study
Notes