Table 1 Subject demographics and baseline characteristics (Efficacy set)
|  | Eutropin group (N = 16) | Comparator group (N = 13) | p-value or mean differencea (95% CI) |
|---|---|---|---|
Gender, male to female ratio | 5/11 | 6/7 | 0.466†|
Age, months | |||
 Mean (SD) | 4.81 (2.04) | 8.04 (5.81) | 0.048‡ |
 Range | 3.0–10.6 | 2.3–24.0 |  |
Gestational age |  |  | 0.299†|
 < 37 weeks, n (%) | 1 (6.25) | 3 (23.08) |  |
 ≥ 37 weeks, < 42 weeks, n (%) | 15 (93.75) | 10 (76.92) |  |
 ≥ 42 weeks, n (%) | 0 (0.00) | 0 (0.00) |  |
Weight at birth, kg | 2.86 (0.34) | 2.49 (0.48) | 0.022§ |
Height SDS | −1.04 (0.94) | −2.08 (0.92) | 1.04 (0.33, 1.76) |
Height velocity, cm/year | 21.46 (12.17) | 19.51 (13.68) | 1.94 (−7.91, 11.80) |
Weight SDS | −1.80 (1.46) | −2.44 (1.20) | 0.65 (−0.39, 1.68) |
BMI, kg/m2 | 15.01 (1.92) | 15.21 (2.02) | −0.20 (−1.71, 1.30) |
Head circumference, cm | 40.76 (1.30) | 42.23 (2.45) | −1.47 (−3.06, 0.12) |
LBM, g | 3438.86 (600.18) | 3691.72 (745.93) | −252.87 (−765.33, 259.60) |
Percent body fat, % | 41.53 (8.51) | 40.04 (10.30) | 1.49 (−5.67, 8.65) |
Bone mineral density, g/cm | 0.37 (0.07) | 0.37 (0.07) | 0.00 (−0.06, 0.05) |
BA, months | 3.1 (1.9) | 5.6 (4.1) | −2.5 (−5.1, 0.1) |
Motor development, score | 14.1 (10.6) | 26.2 (18.1) | −12.2 (− 23.2, − 1.1) |
Cognitive development, score | 28.0 (16.6) | 48.5 (28.9) | −20.5 (− 39.5, − 1.6) |
IGF-I SDS | −2.27 (0.07) | − 2.20 (0.19) | −0.06 (− 0.18, 0.06) |
IGFBP-3 SDS | −0.89 (0.65) | − 0.71 (0.92) | −0.18 (− 0.78, 0.42) |