Yonezawa 2018.
Study characteristics | ||
Methods |
Study design: randomised, parallel, controlled trial Study conducted: March 2014 and June 2015 Treatment arms: 2 Follow‐up: 24 months (eczema, AD, and food allergy) |
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Participants |
Randomised: N = 227 (intervention n = 113, control n = 114) Inclusion criteria:
Exclusion criteria: not reported |
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Interventions | Each group performed skin care from week 1 to week 12 after birth Intervention: moisturising skin care (bathing every 2 days and using lotion daily). The intervention group performed moisturising skin care as follows: (i) routine bathing every 2 days; and (ii) use of a moisturiser 1 or more times per day. If parents were resistant to reducing the frequency of bathing, they were allowed to bathe their newborn daily, but they could use soap only every other day. The researcher provided soap. Parents were also allowed to choose a moisturiser of their choice Comparator: the control group performed the skin care regimen commonly used in Japan as follows: (i) routine bathing daily; and (ii) no moisturiser. Midwives recommended that all mothers routinely bathe their newborn daily. The researcher provided soap. The control group was allowed to apply a moisturiser to their newborn if they wanted to |
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Outcomes |
Primary outcomes: 3‐month outcomes: skin barrier function, by measuring values of transepidermal water loss Secondary outcomes: 3‐month outcomes: skin problems and skin conditions in the diaper area, face, and body recorded in parents'/infants' skin diaries Skin conditions assessed in terms of redness, erythema, dryness, and breakdown Presence of diaper dermatitis assessed using the diaper rash and erythema scoring scale, which rates diaper dermatitis on 7 levels from none to severe Skin problems on the face or the body were assessed by an original score scale that refers to the Neonatal skin Condition Score, which rates a skin condition between 3 and 9 points Infants with skin problems for at least 1 day were considered to have skin problems (p 25). Two year outcomes: parent report of diagnosis of eczema and parent report of diagnosis of food allergy Adverse events: not formally collected |
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Identification |
Country: Japan Setting: Tokyo‐Kita Medical Center Sponsorship source: this study was supported by the Mitsubishi Foundation (Grants for Social Welfare Activities on 2013) and the Mishima Kaiun Memorial Foundation |
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Declarations of interest | None declared | |
Notes |