Table 3.
Treatment Effects on Neurologic Outcomes According to Study Group.*
| Bayley-III Component† | 12-Mo Follow-up | 24-Mo Follow-up | ||||
|---|---|---|---|---|---|---|
| 6-Mo Group | 6-Wk Group | P Value | 6-Mo Group | 6-Wk Group | P Value | |
| Cognitive composite | 0.01 | 0.02 | ||||
|
| ||||||
| No. of participants | 43 | 45 | 42 | 41 | ||
|
| ||||||
| Mean | 89.6±3.0 | 79.5±2.8 | 84.4±2.6 | 76.0±2.6 | ||
|
| ||||||
| Range | 55–115 | 9.5–120 | 55–135 | 55–110 | ||
|
| ||||||
| Language composite | 0.009 | 0.004 | ||||
|
| ||||||
| No. of participants | 41 | 43 | 41 | 41 | ||
|
| ||||||
| Mean | 87.6±3.0 | 76.8±2.9 | 84.6±2.9 | 72.5±2.9 | ||
|
| ||||||
| Range | 47–118 | 11–112 | 47–121 | 47–103 | ||
|
| ||||||
| Receptive-communication scale | 0.05 | 0.003 | ||||
|
| ||||||
| No. of participants | 41 | 43 | 41 | 41 | ||
|
| ||||||
| Mean | 7.5±0.5 | 6.1±0.5 | 7.3±0.5 | 5.2±0.5 | ||
|
| ||||||
| Range | 1–14 | 1–12 | 1–14 | 1–10 | ||
|
| ||||||
| Expressive-communication scale | 0.02 | 0.02 | ||||
|
| ||||||
| No. of participants | 41 | 44 | 41 | 41 | ||
|
| ||||||
| Mean | 8.0±0.5 | 6.5±0.5 | 7.3±0.5 | 5.5±0.5 | ||
|
| ||||||
| Range | 1–13 | 1–13 | 1–13 | 1–11 | ||
|
| ||||||
| Motor composite | 0.03 | 0.01 | ||||
|
| ||||||
| No. of participants | 42 | 44 | 41 | 40 | ||
|
| ||||||
| Mean | 82.6±3.2 | 73.2±3.0 | 85.5±3.3 | 74.1±3.2 | ||
|
| ||||||
| Range | 46–112 | 11–112 | 46–121 | 46–121 | ||
|
| ||||||
| Fine-motor scale | 0.11 | 0.06 | ||||
|
| ||||||
| No. of participants | 41 | 44 | 42 | 40 | ||
|
| ||||||
| Mean | 7.3±0.6 | 6.0±0.6 | 8.0±0.6 | 6.4±0.6 | ||
|
| ||||||
| Range | 1–11 | 0.1–13 | 1–15 | 1–19 | ||
|
| ||||||
| Gross-motor scale | 0.07 | 0.02 | ||||
|
| ||||||
| No. of participants | 42 | 44 | 42 | 40 | ||
|
| ||||||
| Mean | 6.7±0.5 | 5.4±0.5 | 7.0±0.5 | 5.3±0.5 | ||
|
| ||||||
| Range | 1–14 | 0.1–15 | 1–13 | 1–12 | ||
Plus–minus values are means ±SE. Data were adjusted for central nervous system involvement at baseline, prematurity, and age at the initiation of treatment. A P value of less than 0.0071 (i.e., 0.05 divided by 7) was considered to indicate statistical significance, with the use of Bonferroni adjustment for multiple testing. Ranges represent the minimum and maximum values of the raw data.
All the composite scores on the Bayley Scales of Infant and Toddler Development, third edition (Bayley-III), range from 40 to 160, with higher scores indicating better developmental outcomes. All the scale scores on the Bayley-III range from 1 to 19, with higher scores indicating better developmental outcomes. Decimal points in the ranges reflect the specific raw data in the scales for at least one study participant, as captured on the case-report form and verified during the on-site monitoring visits.