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.