Table 1.
Demographic, Clinical, and Surgical Characteristics of the Methylprednisolone and Placebo Groups.
| Characteristic | Methylprednisolone (N=81) | Placebo (N=95) |
|---|---|---|
| Demographics | ||
| Gestational age at birth, weeks | 38.6 (1.2) | 39.0 (1.1) |
| Female sex | 35 (43%) | 35 (36%) |
| Race | ||
| White | 55 (67%) | 60 (63%) |
| Black | 22 (27%) | 27 (28%) |
| Asian | 0 (0%) | 2 (2%) |
| American Indian or Alaska Native | 0 (0%) | 1 (1%) |
| Other | 4 (4%) | 5 (5%) |
| Ethnicity Hispanic | 4 (4%) | 8 (8%) |
| Procedure and Diagnoses - no. (%) | ||
| Corrective | 50 (62%) | 60 (63%) |
| Transposition of the great arteries | 20 (25%) | 24 (25%) |
| Aortic arch hypoplasia with ventricular septal defect | 10 (12%) | 18 (19%) |
| Other | 13 (16%) | 13 (14%) |
| Truncus arteriosus | 6 (8%) | 5 (5%) |
| Tetralogy of Fallot | 1 (1%) | 0 (0%) |
| Palliative | 31 (38%) | 35 (37%) |
| Hypoplastic left heart syndrome | 18 (22%) | 18 (19%) |
| Other single ventricle lesions | 7 (9%) | 11 (12%) |
| Tetralogy of Fallot with pulmonary atresia | 4 (5%) | 2 (2%) |
| Other | 2 (3%) | 4 (4%) |
| Intraoperative Characteristics | ||
| Age at surgery, d | 9.1 (5.4) | 8.2 (5.6) |
| Weight at surgery, kg | 3.2 (0.5) | 3.4 (0.5) |
| STAT mortality risk category | ||
| 1 | 1 (1%) | 0 (0%) |
| 2 | 2 (2%) | 2 (2%) |
| 3 | 16 (19%) | 17 (17%) |
| 4 | 40 (49%) | 49 (51%) |
| 5 | 22 (27%) | 27 (28%) |
| Cardiopulmonary bypass duration, min | 185 (64) | 176 (64) |
| Aortic cross clamp duration, min | 83 (38) | 81 (36) |
| Use of deep hypothermic circulatory arrest | 18 (22%) | 25 (26%) |
| Deep hypothermic circulatory arrest duration, min | 11 (6–28) | 6 (5–12) |
| Modified ultrafiltration | 81 (100%) | 93 (97%) |
Abbreviations: STAT, Society of Thoracic Surgery-European Association for Cardio-Thoracic Surgery mortality risk category. Data are shown as No. (%),mean (SD), or median (interquartile range) as appropriate.