Table 4. Secondary Analyses, According to Birth-Weight Stratum.*.
| Outcome | Aggressive Phototherapy | Conservative Phototherapy | Relative Risk (95% CI)† | |
|---|---|---|---|---|
| no./total no. (%) | ||||
| Death or neurodevelopmental impairment | ||||
| 501–750 g | 272/405 (67) | 270/403 (67) | 1.00 (0.91–1.10) | |
| 751-1000 g | 193/497 (39) | 223/499 (45) | 0.87 (0.75–1.01) | |
| Death‡ | ||||
| 501–750 g | 163/417 (39) | 142/412 (34) | 1.13 (0.96–1.34) | |
| 751–1000 g | 67/529 (13) | 76/532 (14) | 0.90 (0.66–1.21) | |
| Neurodevelopmental impairment | ||||
| 501–750 g | 109/405 (27) | 128/403 (32) | 0.86 (0.70–1.05) | |
| 751–1000 g | 126/497 (25) | 147/499 (29) | 0.86 (0.71–1.05) | |
| Death or profound impairment | ||||
| 501–750 g | 202/403 (50) | 200/400 (50) | 1.00 (0.88–1.14) | |
| 751–1000 g | 108/492 (22) | 137/496 (28) | 0.79 (0.64–0.99)§ | |
| Profound impairment¶ | ||||
| 501–750 g | 39/403 (10) | 58/400 (14) | 0.67 (0.46–0.98)§ | |
| 751–1000 g | 41/492 (8) | 61/496 (12) | 0.68 (0.47–0.99)§ | |
| Death or moderate or severe cerebral palsy | ||||
| 501–750 g | 181/410 (44) | 169/408 (41) | 1.06 (0.91–1.24) | |
| 751–1000 g | 87/519 (17) | 102/515 (20) | 0.86 (0.66–1.11) | |
| Moderate or severe cerebral palsy¶ | ||||
| 501–750 g | 18/410 (4) | 27/408 (7) | 0.66 (0.37–1.19) | |
| 751–1000 g | 20/519 (4) | 26/515 (5) | 0.76 (0.43–1.35) | |
| Death or severe hearing loss | ||||
| 501–750 g | 167/408 (41) | 152/407 (37) | 1.09 (0.93–1.28) | |
| 751–1000 g | 72/517 (14) | 94/515 (18) | 0.77 (0.58–1.02) | |
| Severe hearing loss¶ | ||||
| 501–750 g | 4/408 (1) | 10/407 (2) | 0.40 (0.13–1.26) | |
| 751–1000 g | 5/517 (1) | 18/515 (3) | 0.28 (0.10–0.74)§ | |
| Death or Mental Development Index score <70 | ||||
| 501–750 g | 251/405 (62) | 253/402 (63) | 0.98 (0.89–1.09) | |
| 751–1000 g | 173/500 (35) | 199/502 (40) | 0.88 (0.75–1.03) | |
| Mental Developmental Index score <70 | ||||
| 501–750 g | 88/405 (22) | 111/402 (28) | 0.80 (0.63–1.01) | |
| 751–1000 g | 106/500 (21) | 123/502 (25) | 0.87 (0.69–1.08) | |
| Death or Psychomotor Developmental Index score <70 | ||||
| 501–750 g | 227/404 (56) | 218/399 (55) | 1.03 (0.91–1.16) | |
| 751–1000 g | 130/494 (26) | 152/495 (31) | 0.86 (0.71–1.05) | |
| Psychomotor Developmental Index score <70¶ | ||||
| 501–750 g | 64/404 (16) | 76/399 (19) | 0.83 (0.61–1.13) | |
| 751–1000 g | 63/494 (13) | 76/495 (15) | 0.84 (0.62–1.14) | |
| Death or Mental Developmental Index score <85 | ||||
| 501–750 g | 315/405 (78) | 326/402 (81) | 0.96 (0.89–1.03) | |
| 751–1000 g | 295/500 (59) | 321/502 (64) | 0.92 (0.84–1.02) | |
| Mental Developmental Index score <85 | ||||
| 501–750 g | 152/405 (38) | 184/402 (46) | 0.83 (0.71–0.98)§ | |
| 751–1000 g | 228/500 (46) | 245/502 (49) | 0.93 (0.82–1.06) | |
| Psychomotor Developmental Index score <85 | ||||
| 501–750 g | 117/404 (29) | 130/399 (33) | 0.91 (0.75–1.10) | |
| 751–1000 g | 145/494 (29) | 169/495 (34) | 0.87 (0.73–1.03) | |
| Athetosis¶ | ||||
| 501–750 g | 1/410 (<1) | 5/407 (1) | 0.20 (0.02–1.69) | |
| 751–1000 g | 1/519 (<1) | 5/516 (1) | 0.20 (0.02–1.70) | |
The denominator used to calculate the percentage of infants with a specific outcome was the number of infants randomly assigned to each treatment group, and classified in each birth-weight subgroup, for whom that outcome was known at 18 to 22 months. The Mental and Psychomotor Developmental Indexes are from the Bayley Scales of Infant Development II (on which scores can range from 50 to 150, with 150 indicating the most advanced development).
The relative risk of each outcome was calculated for aggressive phototherapy as compared with conservative phototherapy.
Among infants whose birth weight was 650 g or less, 106 of 214 (50%) died in the aggressive-phototherapy group, as compared with 80 of 212 (38%) in the conservative-phototherapy group (P = 0.03).
P<0.05.
Center was removed from the model owing to the absence of this rare outcome at several centers.