Table 2.
Mortality and neurodevelopmental findings at 18 to 22 months according to treatment assignment
| Variable | Display No. / total No. (%) |
Control | RR (95% CI) | P-value |
|---|---|---|---|---|
| Primary outcome | ||||
| Death or NDI | 127/321(39.6) | 136/306(44.4) | 0.89(0.74,1.07) | 0.223 |
| Death | 79/327(24.2) | 99/309(32.0) | 0.75(0.59,0.97) | 0.028 |
| Death or the following specific components of NDI | ||||
| GMFCS Level 2-5 -- moderate/severe CP | 127/321(39.6) | 136/306(44.4) | 0.89(0.74,1.07) | 0.223 |
| Bilateral blindness | 83/326(25.5) | 99/309(32.0) | 0.79(0.62-1.02) | 0.079 |
| Deafness | 90/327(27.5) | 100/309(32.4) | 0.85(0.67,1.08) | 0.194 |
| Bayley Cognitive <70 | 102/322(31.7) | 113/306(36.9) | 0.86(0.69,1.07) | 0.179 |
| Bayley Language <70 | 115/320(35.9) | 127/305(41.6) | 0.86(0.71,1.05) | 0.163 |
| NDI and specific components of NDI, survivors only | ||||
| NDI | 53/247(21.5) | 40/210(19.1) | 1.12(0.78-1.63) | 0.561 |
| GMFCS Level 2-5 -- moderate/severe CP | 23/246(9.4) | 13/210(6.2) | 1.51(0.78,2.9) | 0.223 |
| Bilateral blindness | 4/247(1.6) | 0/210(0) | 0(0-0) | 0.128 |
| Deafness | 11/248(4.4) | 1/210(0.5) | 9.31(1.21,71.55) | 0.008 |
| Bayley Cognitive <70 | 23/243(9.5) | 15/207(7.3) | 1.31(0.70,2.43) | 0.497 |
| Bayley Language <70 | 36/241(14.9) | 28/206(13.6) | 1.01(0.69,1.74) | 0.787 |
NDI is neurodevelopmental impairment (GMFCS Level 2-5 -- moderate/severe cerebral palsy, blind, deaf, language or cognitive Bayley score <70). CP is cerebral palsy. GMFCS is the Gross Motor Function Classification System. RR is the relative risk of the outcome in the Display group as compared with the Control group. CI denotes confidence interval.