Table 1. Characteristics of infants in the PF and BbF groups.
| PF group (n=49) | BbF group (n=45) | p-value | |
|---|---|---|---|
| Maternal characteristics | |||
| Age (years)1 | 31.7 ± 4.9 | 31.7 ± 5.6 | NS4 |
| Parity1 | 0.66 ± 0.77 | 0.69 ± 0.90 | NS4 |
| Infant characteristics | |||
| Gestational age (days)1 | 274.2 ± 5.8 | 276.6 ± 5.7 | 0.044 |
| Weight at birth (g)1 | 3,058.3 ± 335.1 | 3,120.1 ± 319.8 | NS4 |
| Height at birth (cm)1 | 48.1 ± 1.7 | 48.8 ± 1.3 | NS4 |
| Head circumference at birth (cm)1 | 32.7 ± 1.4 | 33.0 ± 1.5 | NS4 |
| Apgar score at 1 min1 | 8.6 ± 0.8 | 8.6 ± 1.3 | NS4 |
| Apgar score at 5 min1 | 9.6 ± 0.6 | 9.5 ± 0.8 | NS4 |
| Caesarean section2 | 6 (12.2) | 5 (11.1) | NS5 |
| Male sex2 | 22 (44.9) | 20 (44.4) | NS5 |
| Outcomes | |||
| Amount of bottle feeding (mL/day)3 | |||
| One week of age | 302 (189, 423) | 200 (120, 385) | NS6 |
| Two weeks of age | 360 (110, 510) | 213 (76, 375) | NS6 |
| Four weeks of age | 308 (56, 657) | 218 (69, 520) | NS6 |
| Eight weeks of age | 207 (0,722) | 117 (43, 510) | NS6 |
| Mortality2 | 0 (0) | 0 (0) | - |
| Serious adverse event2 | 0 (0) | 2 (4.4) | NS5 |
PF: placebo infant formula; BbF: infant formula containing non-live B. bifidum OLB6378; NS: not significant. 1Mean ± standard deviation, 2Number (%), 3Median and quartile (Q1, Q3), 4Student’s t-test, 5Fisher’s exact test, 6Mann-Whitney U-test. Serious adverse events included two cases of respiratory syncytial virus infection.