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

Lund 2020.

Study characteristics
Methods Study design: randomised, controlled trial
Recruitment date: September 2012 to May 2013
Treatment arms: 2
Follow‐up: 1 post‐bath measurement
Participants Randomisation: N = 100 (vaginal delivery n = 50, caesarean section (C/S) n = 50) (intervention n = 49, control n = 51); randomised according to a balanced block design and stratified according to delivery mode
Inclusion criteria:

  1. Healthy full‐term infant

  2. English‐speaking parents

  3. Parental consent


Exclusion criteria:

  1. Respiratory symptoms requiring oxygen

  2. Intravenous antibiotics

  3. Maternal chorioamnionitis

  4. Congenital anomalies

  5. Admission to the newborn intensive care unit
Interventions All participants were bathed according to the study protocol: immersion bath with water temperature 101°F, depth 5 inches(12.7 cm), which has been shown to be safe even with the umbilical cord in place and swaddle technique to reduce infant distress. The infant was stabilised under a radiant warmer with the 2 study sites ‐ volar forearm and beneath the sternum ‐ exposed for 10 minutes
Intervention: bathed using cleanser
Comparator: bathed with water only
Cleanser ingredients: Johnson & Johnson's Head‐To‐Toe™ was used, as this product was used at the time at this facility. It is a soap‐free liquid cleanser designed for newborn and infant skin; it is sodium lauryl sulfate‐free and pH‐adjusted
Outcomes Primary outcome: skin barrier function, measured by skin surface pH
Secondaryoutcomes: transepidermal water loss (TEWL), hydration of the stratum corneum (SCH)
Adverse events: not reported
Identification Country: USA
Setting: UCSF Benioff Children’s Hospital Oakland, Oakland, CA, USA
Sponsorship Source: this study was supported by a grant from Johnson & Johnson Consumer Co. Inc., and by the National Center for Advancing Translational Sciences, National Institutes of Health, through UCSF‐CTSI Grant Number UL1 TR000004
Declarations of interest This study was supported by a grant from Johnson & Johnson Consumer Co. Inc., and by the National Center for Advancing Translational Sciences, National Institutes of Health, through UCSF‐CTSI Grant Number UL1 TR000004
Notes