TABLE 1.
Patient characteristics at baseline
| Variable | Overall | Randomized to ETV+CPC | Randomized to VPS |
|---|---|---|---|
| Age at randomization in mos | 3.1 (2.6, 4.1) | 3.1 (2.2, 4.2) | 3.1 (2.7, 3.9) |
| Female sex | 39 (39.0%) | 21 (41.2%) | 18 (36.7%) |
| Weight in kg | 6.0 (5.0, 7.0) | 5.6 (4.5, 7.0) | 6.2 (5.4, 7.2) |
| Head circumference in cm | 48.5 (45.2, 50.8) | 48.1 (44.5, 50.0) | 48.7 (45.8, 53.5) |
| BSID-III scaled scores | |||
| Cognitive | 1 (1, 5) | 1 (1, 5) | 1 (1, 5) |
| Expressive language | 3 (1, 6) | 3 (1, 7) | 2 (1, 6) |
| Receptive language | 6 (1, 8) | 6 (2, 9) | 5 (1, 8) |
| Gross motor | 3 (1, 5) | 3 (1, 6) | 2 (1, 4) |
| Fine motor | 3 (1, 5) | 4 (1, 6) | 3 (1, 4) |
| Brain & CSF vol | |||
| CSF vol in cm3 | 783 (570, 1050) | 741 (542, 992) | 824 (639, 1345) |
| Raw brain vol in cm3 | 448 (379, 514) | 435 (378, 510) | 461 (382, 518) |
| Normalized brain vol z-score | −2.2 (−4.4, −1.8)) | −3.3 (−4.2, −1.7) | −2.8 (−4.6, −1.8) |
| Normal brain vol | 15/99 (15.2%) | 7/50 (14.0%) | 8/49 (16.3%) |
Data are expressed as median (interquartile range) or number (percent). Brain and CSF volume data were available for 50 ETV+CPC and 49 VPS infants. There were no significant between-group differences in the characteristics listed except for head circumference (p = 0.03, Mann-Whitney U-test) and CSF volume (p = 0.05, Mann-Whitney U-test).