Table 4.
Outcomes of Children at 30 Months.*
| Outcome | Prenatal Surgery (N = 64) | Postnatal Surgery (N = 70) | Relative Risk (95% CI) | P Value |
|---|---|---|---|---|
| Primary outcome score | 148.6±57.5 | 122.6±57.2 | 0.007 | |
| Primary outcome components | ||||
| Bayley Mental Development Index† | 89.7±14.0 | 87.3±18.4 | 0.53 | |
| Difference between motor function and anatomical levels‡ | 0.58±1.94 | —0.69±1.99 | 0.001 | |
| Bayley Mental Development Index — no./total no. (%)† | ||||
| ≥50 | 60/62 (97) | 59/67 (88) | 1.10 (1.00–1.21) | 0.10 |
| ≥85 | 46/62 (74) | 45/67 (67) | 1.10 (0.88–1.38) | 0.38 |
| Difference between motor function and anatomical levels — no./total no. (%)‡ | 0.002§ | |||
| ≥Two levels better | 20/62 (32) | 8/67 (12) | ||
| One level better | 7/62 (11) | 6/67 (9) | ||
| No difference | 14/62 (23) | 17/67 (25) | ||
| One level worse | 13/62 (21) | 17/67 (25) | ||
| ≥Two levels worse | 8/62 (13) | 19/67 (28) | ||
| Bayley Psychomotor Development Index† | ||||
| Mean | 64.0±17.4 | 58.3±14.8 | 0.03 | |
| ≥50 — no./total no. (%) | 29/62 (47) | 23/67 (34) | 1.36 (0.89–2.08) | 0.15 |
| ≥85 — no./total no. (%) | 10/62 (16) | 4/67 (6) | 2.70 (0.89–8.17) | 0.06 |
| Peabody Developmental Motor Scales¶ | ||||
| Stationary score | 7.4±1.1 | 7.0±1.2 | 0.04 | |
| Locomotion score | 3.0±1.8 | 2.1±1.5 | 0.002 | |
| Object manipulation score | 5.1±2.6 | 3.7±2.1 | <0.001 | |
| Walking independently on examination — no./total no. (%) | 26/62 (42) | 14/67 (21) | 2.01 (1.16–3.48) | 0.01 |
| Walking status — no./total no. (%) | 0.03 | |||
| None | 18/62 (29) | 29/67 (43) | ||
| Walking with orthotics or devices | 18/62 (29) | 24/67 (36) | ||
| Walking without orthotics | 26/62 (42) | 14/67 (21) | ||
| WeeFIM score║ | ||||
| Self-care | 20.5±4.2 | 19.0±4.2 | 0.02 | |
| Mobility | 19.9±6.4 | 16.5±5.9 | 0.003 | |
| Cognitive | 23.9±5.2 | 24.1±5.9 | 0.67 |
Plus–minus values are means ±SD. Listed are data for 134 of 136 patients who underwent randomization before December 1, 2007; data for 2 patients were not available. Before 30 months, there were 5 deaths (2 in the prenatal-surgery group and 3 in the postnatal-surgery group), so data for those infants are not included in any category except the primary-outcome score. Percentages may not total 100 because of rounding.
On the Bayley Scales of Infant Development II, the Mental Development Index and the Psychomotor Development Index are both scaled to have a population mean (±SD) of 100±15, with a minimum score of 50 and a maximum score 150. Higher scores indicate better performance.
For the difference between the motor-function level and the anatomical level, positive values indicate function that is better than expected on the basis of the anatomical level.
The between-group comparison was performed with the use of the Cochran–Armitage test for trend.
On the Peabody Developmental Motor Scales, the mean (±SD) score was 10±3, with a minimum score of 0 and a maximum score of 20. Higher scores indicate better performance.
On the WeeFIM evaluation, the score on the self-care measurement ranges from 8 to 56, and scores on the mobility and cognitive measurements range from 5 to 35, with higher scores indicating greater independence.