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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