Table 2.
Characteristics of Patients with Three-Year-Old Neurodevelopmental Follow-up According to Treatment Group
| Characteristic | Tight glycemic control (n = 124) |
Standard care (n = 145) |
pa |
|---|---|---|---|
| Prerandomization characteristics | |||
| Enrolled in Boston, n (%) | 55 (44) | 73 (50) | 0.33 |
| Age at surgery, median (IQR), mo | 3.8 (1.2–7.1) | 4.2 (1.0–7.7) | 0.87 |
| ≤ 60 d, n (%) | 38 (31) | 47 (32) | 0.79 |
| Female sex, n (%) | 60 (48) | 59 (41) | 0.22 |
| RACHS-1 category ≥ 3 or not assignable, n (%) | 69 (56) | 76 (52) | 0.71 |
| Single ventricle physiology, n (%) | 30 (24) | 36 (25) | 0.77 |
| Premature birth (< 37 weeks), n (%)b | 14 (11) | 21 (15) | 0.47 |
| Genetic anomaly, n (%)c | 27 (22) | 21 (14) | 0.15 |
| Maternal education: high school diploma or lower, n (%)d | 32 (27) | 32 (23) | 0.39 |
| Intraoperative characteristics | |||
| Duration of cardiopulmonary bypass ≥ 150 min, n (%) | 16 (13) | 33 (23) | 0.055 |
| Deep hypothermic circulatory arrest, n (%) | 16 (13) | 29 (20) | 0.14 |
| Delayed sternal closure, n (%) | 10 (8) | 22 (15) | 0.09 |
| Postoperative characteristics | |||
| Treated with insulin therapy in the cardiac ICU, n (%) | 118 (95) | 6 (4) | < 0.001 |
| Time-weighted blood glucose average, mean ± SD, mg/dL | 114 ± 13 | 125 ± 25 | < 0.001 |
| Moderate to severe hypoglycemia (< 50 mg/dL), n (%) | 8 (6) | 5 (3) | 0.39 |
| Cardiac ICU duration of stay, n (%), d | 0.81 | ||
| < 2 | 41 (33) | 54 (37) | |
| 2–4.99 | 54 (44) | 50 (34) | |
| ≥ 5 | 29 (23) | 41 (28) | |
RACHS-1 Risk adjustment in congenital heart surgery
ap values for the comparison between treatment groups were calculated with the use of stratified exact tests for categorical variables, stratified Wilcoxon rank-sum test for age at surgery, or linear regression for time-weighted blood glucose average, with adjustment for site
b One patient was very preterm (gestational age 29 weeks), while the remaining 34 patients were moderate to late preterm (32 to 36 weeks). Premature birth not available for 1 standard care patient (adopted, birth history unknown)
c Genetic anomalies include trisomy 21 (n = 31), 22q11 (n = 8), Charge association (n = 2), 10q24.32 (n = 1), Alagille syndrome (n = 1), trisomy X (n = 1), Williams syndrome (n = 1), and other specific genetic anomalies (8p23.1 deletion, abnormal MLL2, Xq21.31 deletion; n = 1 each)
d Maternal education level not available for 6 tight glycemic control and 4 standard care patients