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. Author manuscript; available in PMC: 2023 Jan 9.
Published in final edited form as: J Neurosurg Pediatr. 2021 Jul 9;28(3):326–334. doi: 10.3171/2021.2.PEDS20949

TABLE 2.

Outcome results at 24 months

Variable Overall Randomized to ETV+CPC Randomized to VPS p Value Difference (95% CI) for ETV+CPC vs VPS
Head circumference in cm 49.5 (46.9, 51.5) 50.0 (48.2, 52.9) 48.0 (46.1, 51.3) 0.008 2.0 (0.5, 3.4)
Treatment failure 33/100 (33.0%) 18/51 (35.3%) 15/49 (30.6%) 0.67 4.7% (−13.7%, 23.1%)
Infection 4 (4.0%) 2 (3.9%) 2 (4.1%) >0.99 −0.2% (−7.8%, 7.5%)
All-cause mortality 15 (15.0%) 9 (17.6%) 6 (12.2%) 0.58 5.4% (−8.5%, 19.3%)
BSID-III scaled scores
 Cognitive, primary outcome 4 (1, 5) 4 (1, 6) 3 (1, 5) 0.17 0 (0, 2)
 Gross motor 1 (1, 5) 1 (1, 9) 1 (1, 3) 0.07 0 (0, 1)
 Fine motor 5 (1, 8) 6 (1, 9) 5 (1, 7) 0.31 0 (0, 2)
Change in BSID-III scaled scores from baseline
 Cognitive 0 (−2, 3) 1 (−2, 4) 0 (−2, 3) 0.64 0 (−1, 2)
 Gross motor 0 (−3, 1) 0 (−3, 4) 0 (−2, 0) 0.62 0 (−1, 2)
 Fine motor 2 (−2, 4) 2 (−3, 4) 1 (−2, 4) 0.67 0 (−2, 1)
Brain vol: raw, in cm3
 At baseline 448 (379, 514) 435 (379, 510) 461 (382, 518) 0.84 −5 (−43, 34)
 At 12 mos 813 (709, 941) 809 (692, 937) 821 (741, 956) 0.21 −33 (−97, 19)
 At 24 mos 831 (725, 923) 774 (688, 920) 863 (740, 948) 0.36 −30 (−95, 30)
Brain vol: normalized for age and sex
 Normalized brain vol at 24 mos, z-score −2.6 (−3.9, −1.4) −3.0 (−4.1, −1.4) −2.4 (−3.6, −1.4) 0.40 −0.3 (−1.1, 0.5)
 Normal brain vol at 24 mos 16/90 (17.8%) 9/45 (20.0%) 7/45 (15.6%) 0.78 4.0% (−11.0%, 20.0%)
 Substantial brain growth from baseline to 24 mos 23/89 (25.8%) 7/44 (15.9%) 16/45 (35.6%) 0.05 −20.0% (−38.0%, −1.0%)
 Substantial brain vol loss from baseline to 24 mos 19/89 (21.3%) 9/44 (20.5%) 10/45 (22.2%) >0.99 −2.0% (−19.0, 15.0%)
 Substantial brain vol loss from 12 to 24 mos 69/90 (76.7%) 34/45 (75.6%) 35/45 (77.8%) >0.99 −2.0% (−20.0%, 15.0%)
 Substantial brain growth from 12 to 24 mos 2/90 (2.2%) 1/45 (2.2%) 1/45 (2.2%) >0.99 −0% (−6.0%, 6.0%)

Data are expressed as median (interquartile range) or number (percent), unless indicated otherwise. The p values were derived from the Mann-Whitney U-test or Fisher’s exact test. Twenty-four–month data for head circumference were available for 90 patients (45 ETV+CPC, 45 VPS), and data for BSID-III scores and volumes were available for 89 patients (44 ETV+CPC, 45 VPS). Hodges-Lehmann estimates and 95% confidence intervals were used for differences in medians and normal approximation for differences in proportions.