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Table 1 Subject demographics and baseline characteristics (Efficacy set)

From: Effects of recombinant human growth hormone treatment on growth, body composition, and safety in infants or toddlers with Prader-Willi syndrome: a randomized, active-controlled trial

  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)
  1. Abbreviations: CI confidence interval, SD standard deviation, SDS standard deviation score, BMI body mass index, LBM lean body mass, BA bone age, IGF-I insulin-like growth factor I, IGFBP-3 IGF-binding protein 3
  2. Data are given as mean (SD) unless otherwise indicated
  3. aMean difference is Eutropin group – comparator group
  4. p-value obtained from Fisher’s exact test
  5. p-value obtained from Wilcoxon’s rank sum test
  6. §p-value obtained from two sample t-test