title: Randomized, controlled trial evaluating a baby wash product on skin barrier function in healthy, term neonates.
abstract: OBJECTIVE
  To examine the hypothesis that the use of a wash product formulated for newborn (<1 month of age) bathing is not inferior (no worse) to bathing with water only.
  
  
  METHODS
  Assessor-blinded, randomized, controlled, noninferiority trial.
  
  
  METHODS
  A teaching hospital in the Northwest of England and in participants' homes.
  
  
  METHODS
  Three-hundred-and-seven healthy, term infants recruited within 48 hours of birth.
  
  
  METHODS
  We compared bathing with a wash product (n = 159) to bathing with water alone (n = 148). The primary outcome was transepidermal water loss (TEWL) at 14 days postbirth; the predefined difference deemed to be unimportant was 1.2. Secondary outcomes comprised changes in stratum corneum hydration, skin surface pH, clinical observations of the skin, and maternal views.
  
  
  RESULTS
  Complete TEWL data were obtained for 242 (78.8%) infants. Wash was noninferior to water alone in terms of TEWL (intention-to-treat analysis: 95% confidence interval [CI] for difference [wash-water, adjusted for family history of eczema, neonate state, and baseline] -1.24, 1.07; per protocol analysis: 95% CI -1.42, 1.09). No significant differences were found in secondary outcomes.
  
  
  CONCLUSIONS
  We were unable to detect any differences between the newborn wash product and water. These findings provide reassurance to parents who choose to use the test newborn wash product or other technically equivalent cleansers and provide the evidence for health care professionals to support parental choice.
authors: School of Nursing, Midwifery and Social Work, The University of Manchester, Manchester, UK. Tina.lavender@manchester.ac.uk
authors: Tina
authors: T
authors: Lavender
authors: Carol
authors: C
authors: Bedwell
authors: Stephen A
authors: SA
authors: Roberts
authors: Anna
authors: A
authors: Hart
authors: Mark A
authors: MA
authors: Turner
authors: Lesley-Anne
authors: LA
authors: Carter
authors: Michael J
authors: MJ
authors: Cork
mesh_terms: D001494:Baths; D003657:Decision Making; D005260:Female; D006801:Humans; D007224:Infant Care / Q000379:methods; D007231:Infant, Newborn; D008297:Male; D024802:Nurse's Role; D016037:Single-Blind Method; D012869:Skin Absorption / Q000502:physiology*; D017592:Skin Care / Q000379:methods*; D012915:Soaps; D047929:Term Birth; D006113:United Kingdom; D014867:Water
chemical_list: D012915:Soaps; D014867:Water