Table 1.
Baseline and demographics (FAS population).
| Baseline parameters |
PEG (n = 77) |
Promelaxin (n = 76) |
p-value |
|---|---|---|---|
| *General characteristics | |||
| Age (days) | 795.49 (400.17) | 729.18 (342.87) | 0.27 |
| Height (cm) | 88.22 (11.89) | 86.37 (10.07) | 0.32 |
| Weight (Kg) | 12.80 (3.00) | 12.03 (2.67) | 0.10 |
| Gender (M) | 32 (41.6%) | 39 (51.3%) | 0.2 |
| Mother VAS (mm) | 61.05 (26.69) | 52.45 (33.42) | 0.08 |
| Father VAS (mm) | 53.64 (28.03) | 46.58 (33.20) | 0.17 |
| PedsQL total score | 21.38 (3.71) | 21.84 (3.09) | 0.40 |
| Stool frequency (week) | 3.54 (3.11) | 3.74 (3.34) | 0.72 |
| ASFS – consistency (n = 25) | |||
| n = 11 | n = 14 | ||
| Type A, n (%) | 1 (9.1%) | 0 (0.0%) | 0.58** |
| Type B, n (%) | 1 (9.1%) | 3 (21.4%) | |
| Type C, n (%) | 3 (27.3%) | 3 (21.4%) | |
| Type D, n (%) | 6 (54.5%) | 8 (57.1%) | |
| *BSFS – consistency (n = 125) | |||
| n = 64 | n = 61 | ||
| Type 1, n (%) | 19 (29.7%) | 24 (39.3%) | 0.70** |
| Type 2, n (%) | 35 (54.7%) | 32 (52.5%) | |
| Type 3, n (%) | 6 (9.4%) | 3 (4.9%) | |
| Type 4, n (%) | 1 (1.6%) | 0 (0.0%) | |
| Type 5, n (%) | 0 (0%) | 0 (0%) | |
| Type 6, n (%) | 2 (3.1%) | 1 (1.6%) | |
| Type 7, n (%) | 1 (1.6%) | 1 (1.6%) | |
Values are either Mean (SD) or n (%).
*
Some missing values. VAS, Visual Analog Scale; ASFS, Amsterdam Stool Form Scale for children aged <1 year; BSFS, Bristol Stool Form Scale for children aged ≥ 1 year.
**
p-value is referred to the different distribution between treatment groups.