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. 2021 Feb 5;2021(2):CD013534. doi: 10.1002/14651858.CD013534.pub2

Garcia Bartels 2012.

Study characteristics
Methods Study design: monocentric, prospective, randomised pilot study
Study conducted: May 2007 to October 2007
Treatment arms: 2
AD follow‐up: baseline second day of life at neonatal ward, followed by 14th and 28th days of life 
Participants Randomised: N = 44 (skin care with baby wipes n = 21; water‐moistened washcloth n = 23 at each diaper change)
Inclusion criteria: healthy full‐term newborns with 37 completed weeks of gestation
Exclusion criteria: 

  1. Sepsis

  2. Congenital malformation

  3. Asphyxia

  4. Hydronephrosis

  5. Intracranial haemorrhage

  6. Immunodeficiency

  7. Skin disease with eruptions covering more than 50% of body surface

  8. Skin maceration or inflammation, or both

  9. Urticaria

  10. Acute⁄chronic disease with temperatures
Interventions Treatments were applied approximately 8 times per 24 hours by parents over 4 weeks 
Both groups obtained a standard skin care regimen, with twice‐weekly bathing in clear tap water without use of a cleanser as described. No additional skin care was given, except for areas of skin trauma or diaper dermatitis
Intervention: skin care with baby wipes (BW). Infants were cleansed with baby wipes during each diaper change
Comparator: water‐moistened washcloth (cotton washcloth moistened with tap water)
Wipes and diaper ingredients: skin care with baby wipes (BW), Penaten (Procter & Gamble Manufacturing GmbH, Euskirchen, Germany), baby wet wipes with aloe vera (aqua, myristyl alcohol, stearyl alcohol, propylene glycol, epilobium angustifolium extract, aloe barbadensis, PEG‐4 laurate, tocopherol, citric acid, lactic acid, tetrasodium‐EDTA phenoxyethanol, iodopropyynyl butylcarbamate, parfum, Johnson & Johnson GmbH, Duesseldorf, Germany), Pampers Diapers ‘‘newborn’’ size, cotton washcloths provided. Tap water pH 7.9 to 8.2
Outcomes Primary outcome: transepidermal water loss
Secondary outcomes: skin pH, SCH, epidermal desquamation, Neonatal Skin Condition Score (NSCS), IL‐1 alpha level 
Adverse effects: not reported
Identification Country: Germany
Setting: Charité ‐Universitätsmedizin Berlin
Sponsorship source: Lida Massoudy’s work was supported by an unrestricted medical grant from Johnson & Johnson GmbH. We thank Dr. Gaelle Bellemere (Johnson & Johnson, Research and Development, France) for support in the IL‐1a analysis and in the D‐Squame technique of blinded samples
Declarations of interest Not reported
Notes