Table 1.
Characteristic | Hydrocortisone (N = 398) | Placebo (N = 402) |
---|---|---|
Maternal age — yr | 28.5±6.2 | 28.2±6.4 |
Race — no./total no. (%)† | ||
Black | 139/388 (35.8) | 168/391 (43.0) |
White | 231/388 (59.5) | 206/391 (52.7) |
Other | 18/388 (4.6) | 17/391 (4.3) |
Hispanic or Latino ethnic group — no./total no. (%)† | 66/392 (16.8) | 60/397 (15.1) |
Mother’s education — no./total no. (%) | ||
Less than high school diploma | 68/396 (17.2) | 59/397 (14.9) |
High school diploma | 101/396 (25.5) | 108/397 (27.2) |
Partial college | 78/396 (19.7) | 85/397 (21.4) |
College degree or more | 66/396 (16.7) | 69/397 (17.4) |
Unknown | 83/396 (21.0) | 76/397 (19.1) |
Received any antenatal glucocorticoids — no./total no. (%) | 343/395 (86.8) | 357/402 (88.8) |
Birth weight — g | 710.3±162.7 | 720.4±171.8 |
Gestational age — wk | 24.8±1.5 | 24.9±1.5 |
Male sex — no (%) | 186 (46.7) | 235 (58.5) |
Median 5-min Apgar score (5th to 95th percentile) | 6 (1–9) | 6 (2–9) |
Small for gestational age — no. (%) | 46 (11.6) | 44 (10.9) |
Multiple birth — no. (%) | 95 (23.9) | 102 (25.4) |
5-min Apgar score ≤5 — no./total no. (%) | 162/396 (40.9) | 155/397 (39.0) |
Median no. of postnatal days at randomization (5th to 95th percentile) | 21 (14–28) | 21 (15–28) |
Highest mode of support at trial entry — no./total no. (%) | ||
High-frequency ventilator | 131/398 (32.9) | 119/401 (29.7) |
Conventional ventilator | 265/398 (66.6) | 282/401 (70.3) |
Nasal IPPV | 2/398 (0.5)‡ | 0/401 |
Fio2 at trial entry | 0.52±0.21 | 0.50±0.20 |
Respiratory index at trial entry§ | 596±350 | 569±319 |
Plus–minus values are means ±SD. Percentages may not total 100 because of rounding. Fio2 denotes fraction of inspired oxygen, and IPPV intermittent positive-pressure ventilation.
Race and ethnic group were reported by the parent or guardian.
Infants were intubated at randomization but extubated before administration of hydrocortisone or placebo.
The respiratory index was calculated as mean airway pressure × Fio2 × 100.