Table 2: Primary outcomes.

Period 1 Period 2 P-value Odds ratio (confidence interval)
Control group Treatment group
No probiotics Infloran
(N = 297) (N = 283)
Incidence of NEC (%)
- All cases 21 (7.1) 10 (3.5) 0.07 0.48 (0.20-1.09)
- Suspected NEC 8 (2.7) 7 (2.5) 1.00 0.92 (0.28-2.94)
- Confirmed NEC ≥ stage II 13 (4.4) 3 (1.1) 0.02 0.23 (0.04-0.87)
Incidence of death (any cause) (%) 20 (6.7) 23 (8.1) 0.53 1.22 (0.63-2.41)
- Incidence of death (secondary to NEC) 5 (1.7) 2 (0.7) 0.45 0.42 (0.04-2.57)

NEC = Necrotising Enterocolitis.