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

Garcia Bartels 2010.

Study characteristics
Methods Study design: monocentric, prospective, randomised study 
Study conducted: October 2006 to May 2007
Treatment arms: 4
AD follow‐up: day 2; weeks 2, 4, and 8 of life
Participants Randomised: N = 64 (WG, bathing with wash gel n = 16; C, bathing and cream n = 16; WG + C, bathing with wash gel plus cream n = 16; B, bathing with water n = 16)
Inclusion criteria:
  1. Healthy full‐term newborns with 37 completed weeks of gestation, aged 48 hours 


Exclusion criteria:
  1. Sepsis

  2. Serious congenital malformations

  3. Asphyxia

  4. Hydronephrosis

  5. Severe intracranial haemorrhage

  6. Immunodeficiency

  7. Pre‐existing skin disease with eruptions covering more than 50% of body surface

  8. Relevant skin maceration or inflammation ⁄ irritation

  9. Urticaria

  10. Acute or chronic disease with temperature below 35°C or above 40°C

Interventions Intervention: full‐term neonates (32 girls, 32 boys) aged ≤ 48 hours were randomly assigned to 4 groups (including one comparator group, each n = 16) receiving treatment twice weekly from day 7 until week 8 of life. 
  1. Group WG, bathing with pH 5.5 wash gel (Top‐To‐Toe Baby Gel Penaten, Johnson & Johnson GmbH, Duesseldorf, Germany). 

  2. Group C, bathing with clear water and afterwards topical cream (Baby Caring Facial & Body Cream Penaten, Johnson & Johnson GmbH, Duesseldorf, Germany). 

  3. Group WG + C, bathing with wash gel and topical cream.


All neonates were washed 3 times with a cotton wash cloth, moistened with water, until day 7
Bathing lasted about 5 minutes using tap water at temperature 37 to 38°C, pH 7.9 to 8.2, hardness 13.4 dH (range 7 to 25 dH). Diapers from Pampers Baby Dry for Newborns were provided. Parents were instructed to avoid treating skin with any other skin care products. Topical products were allowed on areas of skin trauma or diaper dermatitis, including: triclosan 1% cream, octenidin ⁄ phenoxyethanol solution, zinc paste (optional with nystatin). To remove meconium: oil and vaseline were allowed.
Comparator: Group B, bathing with clear water 
Outcomes
  1. Transepidermal water loss

  2. Stratum corneum hydration

  3. Skin pH

  4. Sebum


Adverse effects: no adverse events reported
Identification Country: Germany 
Setting: Department of Dermatology, Clinic for Neonatology CCM at Charité‐Universitätsmedizin Berlin, and Department of Gynaecology, Clinic Dahme‐Spreewald
Sponsorship source: the work of Franziska Prosch was supported by an unrestricted medical grant from Johnson & Johnson
Declarations of interest The funders had no input regarding study design or conduct, data analysis or interpretation, manuscript
preparation, or the decision to submit the results for publication
Notes