Impact of Tight Glycemic Control on Neurodevelopmental Outcomes at 1 Year of Age for Children with Congenital Heart Disease: A Randomized Controlled Trial

J Pediatr. 2016 Jul:174:193-198.e2. doi: 10.1016/j.jpeds.2016.03.048. Epub 2016 Apr 23.

Abstract

Objective: To assess the association of postoperative tight glycemic control and hypoglycemia in children undergoing cardiac surgery with neurodevelopmental outcomes at 1 year of age.

Study design: A 2-center, prospective, randomized trial of postoperative tight glycemic control vs standard care was conducted in 980 children undergoing cardiac surgery. Neurodevelopmental outcomes were assessed at nine to 18 months using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Adaptive Behavior Assessment System, Second Edition, the Ages and Stages Questionnaire, Third Edition, and the Brief Infant Toddler Social-Emotional Assessment.

Results: Neurodevelopmental follow-up was performed on 237 patients with a mean age of 13 months. No significant treatment group differences were found in the Bayley-III and Adaptive Behavior Assessment System, Second Edition composite scores or percentage at risk based on the Ages and Stages Questionnaire, Third Edition and the Brief Infant Toddler Social-Emotional Assessment. Patients who experienced moderate to severe hypoglycemia (n = 8) had lower Bayley-III composite scores compared with patients with no to mild hypoglycemia, even after controlling for factors known to be associated with poorer neurodevelopmental outcomes.

Conclusion: For infants undergoing cardiac surgery, tight glycemic control did not impact neurodevelopmental outcomes compared with standard care. These data suggest a possible association between moderate to severe hypoglycemia and poorer neurodevelopmental outcomes at 1 year of age.

Trial registration: ClinicalTrials.gov: NCT00443599.

Keywords: cardiac; cardiac surgery; glycemic control/blood glucose; hypoglycemia; neurodevelopment.

Publication types

  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, N.I.H., Extramural

MeSH terms

  • Algorithms
  • Blood Glucose
  • Cardiopulmonary Bypass / adverse effects*
  • Female
  • Follow-Up Studies
  • Heart Defects, Congenital / surgery*
  • Humans
  • Hyperglycemia / prevention & control*
  • Hypoglycemia / prevention & control*
  • Infant
  • Male
  • Neurodevelopmental Disorders / epidemiology*
  • Postoperative Care
  • Postoperative Complications / prevention & control*
  • Prospective Studies
  • Treatment Outcome

Substances

  • Blood Glucose

Associated data

  • ClinicalTrials.gov/NCT00443599