Skip to main content

Table 1 Demographic and baseline participant characteristics (n = 88)

From: Potentiation of cord blood cell therapy with erythropoietin for children with CP: a 2 × 2 factorial randomized placebo-controlled trial

Groupa Group A (n = 22) Group B (n = 24) Group C (n = 20) Group D (n = 22)
Demographics
 Sex, no. % male 10 (45.5%) 11 (45.8%) 10 (50.0%) 15 (68.2%)
 Age, year; mean (SD; range)b 3.0 (1.2; 1.5–6.3) 2.9 (1.3; 1.0–5.0) 3.4 (1.3; 1.1–5.8) 3.0 (1.1; 1.2–6.0)
 Gestational age, weeks; mean (SD; range) 32.3 (4.8; 26–41) 31.9 (3.9; 26–40) 31.9 (4.3; 26–40) 33.6 (5.4; 24–42)
 Preterm, no. (%) 16 (72.7%) 20 (83.3%) 16 (80.0%) 13 (59.1%)
 Birth weight (SD; range), kg 1.9 (.8; .6–3.6) 1.9 (.8; .8–3.4) 1.9 (.8; .7–3.5) 2.2 (.9; .7–4.2)
 NBW/LBW/VLBW/ELBWc 6/7/8/1 5/10/7/2 5/8/5/2 10/7/3/2
 GMFCS (I/II/III/IV/V) 1/2/5/6/8 2/2/5/3/12 1/6/3/7/3 0/1/5/10/6
 Typology (SB/SU/D/C/A)d 18/0/3/0/1 20/0/4/0/0 15/0/4/0/1 17/0/4/0/1
Baseline primary outcome measures
 GMFM 38.0 (22.9) 31.9 (24.4) 44.3 (21.8) 31.1 (16.2)
 GMPM 34.1 (14.7) 32.7 (13.6) 38.1 (11.5) 35.9 (11.2)
 BSID-II mental raw score 106.4 (38.5) 99.2 (44.1) 121.7 (33.2) 100.9 (39.1)
 BSID-II motor raw score 49.8 (19.9) 48.3 (24.5) 61.1 (20.1) 47.5 (21.5)
MRI finding s[49]
 Normal (n = 0) 0 0 0 0
 Acquired lesions (n = 87)
  Periventricular leukomalacia (n = 66) 17 20 14 15
  Diffuse encephalopathy (n = 18) 4 4 5 5
  Focal ischemia/hemorrhage (n = 1) 0 0 0 1
  Multicystic encephalomalacia (n = 2) 1 0 0 1
 Malformations (n = 0)
  Cortical dysplasia (n = 0) 0 0 0 0
  Schizencephaly (n = 0) 0 0 0 0
  Corpus callosum agenesis (n = 0) 0 0 0 0
 Miscellaneous/unknown (n = 1)     
  Miscellaneous etiologies (n = 0) 0 0 0 0
  Abnormality of white matter signal (n = 1) 0 0 1 0
  1. Values represent number of patients unless otherwise noted. No baseline characteristics were significantly different among four groups (P value > 0.05 for all comparisons). Baseline primary outcome measures are shown as means (SD)
  2. aGroup A (n = 22) received UCB and EPO, group B (n = 24) received UCB and placebo EPO, group C (n = 20) received placebo UCB and EPO, and group D (n = 22) received placebo UCB and placebo EPO
  3. bAge at the time of intervention, corrected for preterm birth
  4. cNBW was defined as birth body weight ≥ 2500 g, LBW < 2500 g, VLBW < 1500 g, and ELBW < 1000 g
  5. dTypology was divided as follows: SB, SU, D, C, and A
  6. Abbreviations: Birth weight (NBW normal birth weight, LBW low birth weight, VLBW very low birth weight, ELBW extremely low birth weight), BSID-II Bayley scales of infant development-II, EPO erythropoietin, GMFM gross motor function measure, GMPM gross motor performance measure, Typology (SB spastic bilateral, SU spastic unilateral, D dystonic, C choreoathetoid, A ataxic), UCB umbilical cord blood