Impact of tight glycemic control and hypoglycemia after pediatric cardiac surgery on neurodevelopmental outcomes at three years of age: Findings from a randomized clinical trial

Table 1 Patient Characteristics According to Three-Year-Old Neurodevelopmental Follow-up Status

Characteristic	ND follow-up (n = 269)	No ND follow-up (n = 603)	p^a
*Prerandomization characteristics*
Enrolled in Boston, n (%)	128 (48)	442 (73)	< 0.001
Age at surgery, median (IQR), mo	3.9 (1.1–7.6)	4.9 (2.4–10.6)	0.02
≤ 60 d, n (%)	85 (32)	126 (21)	0.008
Female sex, n (%)	119 (44)	279 (46)	0.82
RACHS-1 category ≥ 3 or not assignable, n (%)	145 (54)	295 (49)	0.40
Single ventricle physiology, n (%)	66 (25)	85 (14)	0.01
Premature birth (< 37 weeks), n (%)^b	35 (13)	89 (15)	0.45
Genetic anomaly, n (%)	48 (18)	117 (19)	0.77
*Intraoperative characteristics*
Duration of cardiopulmonary bypass ≥ 150 min, n (%)	49 (18)	124 (21)	0.99
Deep hypothermic circulatory arrest, n (%)	45 (17)	77 (13)	0.19
Delayed sternal closure, n (%)	32 (12)	57 (9)	0.62
*Postoperative characteristics*
Tight glycemic control group, n (%)	145 (54)	289 (48)	0.11
Treated with insulin therapy in the cardiac ICU, n (%)	124 (46)	283 (47)	0.60
Time-weighted blood glucose average, mean ± SD, mg/dL	120 ± 21	120 ± 22	0.88
Moderate to severe hypoglycemia (< 50 mg/dL), n (%)	13 (5)	34 (6)	0.41
Cardiac ICU duration of stay, n (%), d			0.10
< 2	95 (35)	221 (37)
2–4.99	104 (39)	211 (35)
≥ 5	70 (26)	171 (28)

ND Neurodevelopmental, RACHS-1 Risk adjustment in congenital heart surgery
^ap values for the comparison between 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 In the ND follow-up group, premature birth not available for 1 patient (adopted, birth history unknown)

ISSN: 1471-2431