Table 2.
Primary Outcomes and Their Components.*
| Outcome | Hydrocortisone (N = 398) | Placebo (N = 402) | Rate Ratio (95% CI)† |
|---|---|---|---|
| Efficacy | |||
| Survival without moderate or severe BPD at 36 wk of postmenstrual age — no. (%) | 66 (16.6) | 53 (13.2) | 1.27 (0.93–1.74) |
| Death by 36 wk of postmenstrual age — no. (%) | 19 (4.8) | 28 (7.0) | 0.66 (0.38–1.16)‡ |
| Moderate or severe BPD at 36 wk of postmenstrual age — no./total no. (%) | 313/379 (82.6) | 321/374 (85.8) | 0.96 (0.91–1.02) |
| Safety § ¶ | |||
| Survival without moderate or severe NDI — no./total no. (%) | 132/358 (36.9) | 134/359 (37.3) | 0.98 (0.81–1.18) |
| Survival without severe NDI — no./total no. (%) | 230/358 (64.2) | 231/359 (64.3) | 1.01 (0.90–1.12) |
| Known to have died by follow-up — no. (%) | 43 (10.8) | 46 (11.4) | 0.91 (0.62–1.34)‡ |
| Moderate or severe NDI in survivors — no./total no. (%) | 183/315 (58.1) | 179/313 (57.2) | 1.03 (0.90–1.17) |
BPD denotes bronchopulmonary dysplasia, and CI confidence interval.
Rate ratios were adjusted for center and gestational-age strata.
Shown is the Mantel–Haenszel estimate.
Neurodevelopmental impairment (NDI) was defined as one or more of the following: a Bayley Scales of Infant and Toddler Development–III (Bayley-III) cognitive score of less than 85 (standardized mean [±SD], 100±15; range, 55 to 145) or a Bayley-III motor score of less than 85 (standardized mean, 100; range, 45 to 155), with lower scores indicating greater impairment; a Gross Motor Function Classification System (GMFCS) level of at least II (on a scale from level I to V, with I indicating normal and higher levels indicating greater impairment); severe vision impairment in both eyes (consistent with a visual acuity of <20/200); or bilateral hearing impairment with or without amplification (on the basis of observation during the trial visit; report by the parent, guardian, or primary caregiver; or chart review).
NDI severity could not be determined for 11 infants. According to the protocol for the follow-up study, from which we obtained the NDI data in our trial, NDI could be determined if a component of a binary indicator in the NDI definition was known as “Yes,” but the severity level could be determined only when all components of level of severity were documented.