Secondary AD outcome
The cumulative incidence of AD at 6 months was 18.3% in the IG vs. 36.4% in the CG, p = 0.002 [RR (95%CI): 0.503 (0.325, 0,779)]. The point prevalence at 6 months was 18.3% in the IG and 35.0% in the CG, p = 0.004 [RR (95%CI): 0.524 (0.337, 0813)], Table 3.
Time-to-event survival analysis using the Kaplan- Meier method demonstrates that the IG maintained AD-free skin for a longer period in the first 12 months than the CG (p = 0.016, log-rank test, Figure 3). Of those with AD outcome data at 6 and 12 months (n = 117 intervention, n =137 control), 7.7% of IG and 8.0% of CG infants were diagnosed at ≤6 months, but no longer met the criteria at 12 months (p = 1.0). The prevalence of AD onset between 6 and 12 months was 13.7% and 9.5% in the IG and CG, respectively (p = 0.397) and 10.3% vs. 29.2% met the criteria at both 6 and 12 months (p < 0.001), (See Supplementary Figure 1). SCORADs were completed for those ≥6 months at diagnosis (n = 55). There was no significant difference in SCORAD total scores at diagnosis between the groups [median (IQR) SCORAD: IG 11.3 (8.0, 18.4), vs. CG 12.3 (7.4, 16.0), p = 0.888].
A similar, but non-significant relative risk was observed for the primary outcome in the per-protocol analyses [Questionnaire per-protocol analysis RR (95%) CI: 0.713 (0.501, 1.014), P = 0.078); Diary per-protocol analysis RR (95% CI): 0.745 (0.474, 1.173),P = 0.253], (See Supplementary Tables 1-4).