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

Abstract Background: Studies examining the impact of randomization to tight glycemic control (TGC) and resultant hypoglycemia on later neurodevelopmental outcomes have produced mixed results. Our study examined this association in children undergoing cardiac surgery.Methods: Participants who were enrolled in the Safe Pediatric Euglycemia after Cardiac Surgery (SPECS) trial returned for neurodevelopmental (ND) follow-up between 30 to 42.5 months of age. ND outcomes were assessed using the Bayley Scales of Infant and Toddler Development, Third Edition. ND scores were compared between the TGC and standard care groups and between patients with moderate to severe and no to mild hypoglycemia. To increase sample size and power, we combined the three-year-old assessments with previously collected assessments (at 9 to 42.5 months of age) to further examine differences between groups.Results: At three years of age, there were no statistically significant differences in ND outcomes according to treatment group or hypoglycemia status. In the combined analysis, we found no group differences. However, children who experienced moderate to severe hypoglycemia had lower scores on the Bayley-III cognitive and motor domains compared to children with no to mild hypoglycemia. Conclusions: For infants undergoing cardiac surgery, moderate to severe hypoglycemia, but not randomization to TGC, was associated with worse ND outcomes.Trial Registration: ClinicalTrials.gov NCT00443599. Registered: November 2016.