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Table 4 Comparison of secondary outcomes at follow-up by randomised group under intention-to-treat analyses

From: Effect on skin hydration of using baby wipes to clean the napkin area of newborn babies: assessor-blinded randomised controlled equivalence trial

Analysis (ITT) Wipes (n = 124) Water (n = 130) Group effect P-value 95 % CI for difference in adjusted means
pH1, mean (SD) (N = 118) 5.93 (0.58) (N = 122) 5.65 (0.62) 0.356 −0.1 to 0.4
TEWL1, mean (SD) (n = 119) 17.8 (7.0) (N = 124) 19.0 (10.6) 0.486 −3.9 to 1.2
Log erythema1, mean (SD) (n = 118) 6.27 (0.14) (n = 129) 6.30 (0.14) 0.177 −0.06 to 0.001
Coliform bacteria2, median (IQR) (n = 122) 2000 (53 to 45250) (n = 128) 4850 (168 to 119500) 0.913 -
Candida species2, median (IQR) 0 (0 to 0) 0 (0 to 0) 0.454 -
Mother-reported dermatitis total 4-week score     
Complete responses, Median (IQR) (n = 93) 1.00 (0 to 7.5) (n = 96) 2.5 (0 to 12.75) 0.025 -
Partial responses, Median (IQR) (n = 108) 1.00 (0 to 7) (n = 116) 2.33 (0 to 11.8) 0.016 -
Midwife-reported dermatitis at week 4, n (%)    0.300 -
No evidence of rash 108 (87.1) 109 (83.8)   
Slight rash 13 (10.5) 14 (10.8)   
Mild-moderate rash 2 (1.6) 5 (3.8)   
Moderate-severe rash 1 (0.8) 2 (1.5)   
  1. 1Buttocks.
  2. 2Peri-anal area.