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