Table 1.
Characteristics and outcomes of the intent-to-treat population.
| N Group n = 31 | L Group n = 30 | H Group n = 37 | Difference | |
|---|---|---|---|---|
| Characteristics | ||||
| Gestational age, week a | 35.4 ± 1.8 | 35.1 ± 1.4 | 34.6 ± 1.7 | N.S. † |
| Body weight at birth, g a | 2027 ± 264 | 2077 ± 208 | 1957 ± 244 | N.S. † |
| Body weight at 6 months, g a | 6915 ± 729 | 6889 ± 662 | 7015 ± 736 | N.S. † |
| Apgar score at 1 min ≤ 3 b | 0 (0) | 0 (0) | 0 (0) | N.S. ‡ |
| Apgar score at 5 min ≥ 7 b | 31 (100) | 30 (100) | 37 (100) | N.S. ‡ |
| Male sex b | 14 (45) | 16 (53) | 18 (49) | N.S. ‡ |
| Caesarean section b | 25 (80) | 24 (80) | 31 (80) | N.S. ‡ |
| Multiple pregnancy b | 16 (51) | 16 (53) | 20 (54) | N.S. ‡ |
| Outcomes | ||||
| Mortality b | 0 (0) | 0 (0) | 0 (0) | N.S. ‡ |
| Sepsis b | 0 (0) | 0 (0) | 0 (0) | N.S. ‡ |
| Severe digestive symptom b | 0 (0) | 0 (0) | 0 (0) | N.S. ‡ |
N group = control; L group = live OLB6378; H group = non-live OLB6378; a Mean ± standard deviation, b Number (%), † One-way ANOVA, ‡ Fisher’s exact test.