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 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)	p^a
*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

ISSN: 1471-2431