TABLE 2.
Demographics and baseline characteristics of infants per intervention group of the per protocol population (n = 298)
| Statistic | scGOS/lcFOS (N = 75) | scGOS/lcFOS +15% FERM (N = 79) | scGOS/lcFOS +50% FERM (N = 79) | 50% FERM (N = 65) | |
| Sex F | |||||
| Male | n (%) | 39 (52.0%) | 37 (46.8%) | 39 (49.4%) | 33 (50.8%) |
| Female | n (%) | 36 (48.0%) | 42 (53.2%) | 40 (50.6%) | 32 (49.2%) |
| Mode of birth F | |||||
| Natural | n (%) | 61 (81.3%) | 60 (75.9%) | 58 (73.4%) | 52 (80.0%) |
| C-section | n (%) | 14 (18.7%) | 19 (24.1%) | 21 (26.6%) | 13 (20.0%) |
| Ethnicity F | |||||
| Caucasian/White | n (%) | 67 (89.3%) | 71 (89.9%) | 72 (91.1%) | 61 (93.8%) |
| Black | n (%) | 2 (2.7%) | 1 (1.3%) | 3 (3.8%) | 1 (1.5%) |
| Asian | n (%) | 0 (0.0%) | 1 (1.3%) | 0 (0.0%) | 0 (0.0%) |
| Combination | n (%) | 3 (4.0%) | 2 (2.5%) | 3 (3.8%) | 0 (0.0%) |
| Other | n (%) | 3 (4.0%) | 4 (5.1%) | 1 (1.3%) | 3 (4.6%) |
| Country F | |||||
| Belgium | n (%) | 28 (37.3%) | 24 (30.4%) | 25 (31.6%) | 22 (33.8%) |
| France | n (%) | 26 (34.7%) | 34 (43.0%) | 33 (41.8%) | 25 (38.5%) |
| Ireland | n (%) | 21 (28.0%) | 21 (26.6%) | 21 (26.6%) | 18 (27.7%) |
| Order of birth F | |||||
| First | n (%) | 28 (37.3%) | 29 (36.7%) | 34 (43.0%)* | 22 (33.8%)* |
| Second | n (%) | 31 (41.3%) | 34 (43.0%) | 36 (45.6%) | 27 (41.5%) |
| Third | n (%) | 14 (18.7%) | 12 (15.2%) | 6 (7.6%) | 16 (24.6%) |
| >Third | n (%) | 2 (2.7%) | 4 (5.1%) | 3 (3.8%) | 0 (0.0%) |
| Age at first visit, day W | Median (min-max) | 4 (0–28) | 4 (0–28) | 6 (0–28) | 5 (0–28) |
| Gestational age, wk W | Median (min-max) | 39 (37–41) | 40 (37–41) | 40 (37–41) | 39 (37–41) |
| Weight at birth, g T | Mean ± SD | 3336 ± 429 | 3378 ± 358 | 3370 ± 368 | 3444 ± 377 |
| Length at birth, cm W | Median (min-max) | 50 (45–54) | 50 (46–54) | 50 (45–53) | 50 (46–54) |
| Maternal age, yr T | Mean ± SD | 29.4 ± 4.9 | 30.3 ± 5.2 | 29.5 ± 5.1 | 29.5 ± 4.9 |
| Maternal BMI, kg/m2 W | Median (min-max) | 24 (17–43) | 24 (20–45) | 25 (16–39) | 25 (16–36) |
| Paternal age, yr T | Mean ± SD | 32.2 ± 5.4 | 32.6 ± 6.2 | 32.1 ± 5.6 | 32.7 ± 5.3 |
| Paternal BMI, kg/m2 W | Median (min-max) | 25 (18–40) | 26 (18–34) | 26 (19–36) | 26 (19–36) |
BMI = body mass index; 15% FERM = infant formula consisting of 15% fermented infant formula; 50% FERM = infant formula consisting of 50% fermented infant formula; scGOS/lcFOS = short-chain galacto-oligosaccarides and long-chain fructo-oligosaccharides; SD = standard deviation.
*Values are significantly different. For the analysis of continuous data 2 sample t tests (T) were used and Wilcoxon rank sum tests (W) were used in case of violation of normality assumption and/or presence of outliers. Categorical response parameters were analyzed by using Fisher exact tests (F).