TABLE 4

Neurodevelopmental Outcomes

DarbeEpoESA a PlaceboUnadjustedAdjusted for Gender, Maternal Education
n = 27n = 29P * n = 56n = 24Odds Ratio (95% CI)P * Odds Ratio (95% CI)P *
Cognitive score <850 (0)3 (10.3)0.123 (5.4)6 (25.0)0.17 (0.04–0.75)0.020.18 (0.04–0.82)0.03
Cognitive score <800 (0)3 (10.3)0.123 (5.4)5 (20.8)0.22 (0.05–0.99)0.050.24 (0.05–1.13)0.07
Cognitive score <700 (0)1 (3.5)0.501 (1.8)2 (8.3)0.20 (0.02–2.32)0.200.24 (0.02–2.93)0.26
NDI, b N (%)3 (11.1)4 (13.8)0.887 (12.5)10 (41.7)0.20 (0.06–0.62)0.0050.21 (0.07–0.68)0.009
CP, c 0 (0)0 (0)1.000 (0)5 (20.8)N/A0.002N/A<0.001
Visual deficit2 (7.4)0 (0)0.272 (3.6)1 (4.2)0.85 (0.07–9.87)0.910.72 (0.06–8.74)0.80
Hearing deficit0 (0)1 (3.5)0.501 (1.8)1 (4.2)0.42 (0.03–6.98)0.540.48 (0.03–8.59)0.62
NDI or death, N (%)4/28 (14.3)5/30 (16.7)0.929/58 (15.5)13/27 (48.2)0.20 (0.07–0.56)0.0020.22 (0.07–0.70)0.01
Moderate NDI, d N (%)3 (11.1)2 (6.9)0.455 (8.9)9 (37.5)0.16 (0.05–0.56)0.0040.18 (0.05–0.63)0.008
Moderate NDI or death, N (%)4/28 (14.3)3/30 (10.0)0.487/58 (12.1)12/27 (44.4)0.17 (0.06–0.51)0.0020.20 (0.06–0.67)0.009
  • * P values for comparisons between Darbe and Epo were computed using 2 methods depending on characteristics of the data. For the NDI measures, P values were computed using logistic regression with gender and maternal education as covariates. For the remaining measures, P values were computed using ANCOVA with only gender as a covariate. Percentages for NDI or death include deaths during initial hospitalization. CI, confidence interval. N/A, not applicable.

  • a Treated groups are combined.

  • b NDI is defined as having either CP, visual deficit, hearing deficit, or a cognitive score <85.

  • c Given the absence of CP cases in the ESA treatment group, odds ratios cannot be accurately estimated. P values given for CP were computed using Fisher’s exact tests for the unadjusted P value and using ANCOVA with gender as the only covariate for the remaining P values.

  • d Moderate NDI is defined as having either CP, visual deficit, hearing deficit, or a cognitive score <70.