Table 3. Primary and Other Outcomes at 18 to 22 Months.*.
| Outcome | Aggressive Phototherapy | Conservative Phototherapy | Relative Risk (95% CI)† |
|---|---|---|---|
| no./total no. (%) | |||
| Death or neurodevelopmental impairment | 465/902 (52) | 493/902 (55) | 0.94 (0.87–1.02) |
| Death‡ | 230/946 (24) | 218/944 (23) | 1.05 (0.90–1.22) |
| Neurodevelopmental impairment | 235/902 (26) | 275/902 (30) | 0.86 (0.74–0.99)§ |
| Profound impairment¶ | 80/895 (9) | 119/896 (13) | 0.68 (0.52–0.89)§ |
| Death or profound impairment | 310/895 (35) | 337/896 (38) | 0.92 (0.82–1.03) |
| Cerebral palsy| | |||
| Mild, moderate, or severe | 81/929 (9) | 91/924 (10) | 0.89 (0.67–1.18) |
| Moderate or severe | 38/929 (4) | 53/923 (6) | 0.71 (0.47–1.07) |
| Death or cerebral palsy | |||
| Mild, moderate, or severe | 311/929 (34) | 309/924 (33) | 1.00 (0.89–1.13) |
| Moderate or severe | 268/929 (29) | 271/923 (29) | 0.99 (0.86–1.13) |
| Severe hearing loss| | 9/925 (1) | 28/922 (3) | 0.32 (0.15–0.68)§ |
| Death or severe hearing loss | 239/925 (26) | 246/922 (27) | 0.97 (0.84–1.12) |
| Blindness| | 2/928 (<1) | 7/924 (1) | 0.28 (0.06–1.37) |
| Death or blindness | 232/928 (25) | 225/924 (24) | 1.03 (0.88–1.19) |
| Mental Developmental Index score <70 | 194/905 (21) | 234/904 (26) | 0.83 (0.71–0.98)§ |
| Death or Mental Developmental Index score <70 | 424/905 (47) | 452/904 (50) | 0.94 (0.86–1.02) |
| Psychomotor Developmental Index score <70 | 127/898 (14) | 152/894 (17) | 0.84 (0.68–1.04) |
| Death or Psychomotor Developmental Index score <70 | 357/898 (40) | 370/894 (41) | 0.96 (0.86–1.06) |
| Mental Developmental Index score <85 | 380/905 (42) | 429/904 (47) | 0.89 (0.80–0.98)§ |
| Death or Mental Developmental Index score <85 | 610/905 (67) | 647/904 (72) | 0.94 (0.89–1.00)§ |
| Psychomotor Developmental Index score <85 | 262/898 (29) | 299/894 (33) | 0.88 (0.77–1.01) |
| Death or Psychomotor Developmental Index score <85 | 492/898 (55) | 517/894 (58) | 0.95 (0.88–1.03) |
| Athetosis| | 2/929 (<1) | 10/923 (1) | 0.20 (0.04–0.90)§ |
| Death or athetosis | 232/929 (25) | 228/923 (25) | 1.01 (0.87–1.17) |
| Seizures| | 29/933 (3) | 28/925 (3) | 1.03 (0.62–1.71) |
| Normal gross motor function | 556/929 (60) | 545/923 (59) | 1.01 (0.94–1.08) |
| Ability to walk fluently** | 544/929 (59) | 529/924 (57) | 1.02 (0.95–1.10) |
| Fine pincer grasp | 606/929 (65) | 582/922 (63) | 1.03 (0.97–1.10) |
| Weight below 5th percentile for age | 242/929 (26) | 255/924 (28) | 0.94 (0.81–1.10) |
| Fronto-occipital circumference below 5th percentile for age | 120/929 (13) | 128/922 (14) | 0.93 (0.74–1.17) |
The denominator used to calculate the percentage of infants with a specific outcome was the number of infants randomly assigned to each treatment group 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.
The mean (±SD) age at death was 57±98 days (range, 1 to 673) in the aggressive-phototherapy group and 52±88 days (range, 0 to 622) in the conservative-phototherapy group. The causes of death and the Kaplan–Meier survival estimates are shown in Table 1 and Figure 2 in the Supplementary Appendix.
P<0.05.
Infants with profound impairment included 22 with a Mental Developmental Index score of 50 and 121 with a score of less than 50.
Center was removed from the model owing to the absence of this rare outcome at several centers.
The ability to walk fluently was defined as the ability to take 10 steps, unassisted, with a normal gait for the age.