Impact of Tight Glycemic Control on Neurodevelopmental Outcomes at 1 Year of Age for Children with Congenital Heart Disease: A Randomized Controlled Trial.
To assess the association of postoperative tight glycemic control and hypoglycemia in children undergoing cardiac surgery with neurodevelopmental outcomes at 1 year of age.



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.



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.



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.



ClinicalTrials.gov: NCT00443599.
Cardiac Neurodevelopmental Program, Boston Children's Hospital and Harvard Medical School, Boston, MA; Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston, MA. Electronic address: anjali.sadhwani@childrens.harvard.edu.
Anjali
A
Sadhwani
Department of Cardiology, Boston Children's Hospital and Harvard Medical School, Boston, MA.
Lisa A
LA
Asaro
Division of Cardiology, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI; Department of Pediatrics and Communicable Diseases, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI.
Caren
C
Goldberg
Cardiac Neurodevelopmental Program, Boston Children's Hospital and Harvard Medical School, Boston, MA; Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston, MA.
Janice
J
Ware
Department of Pediatrics and Communicable Diseases, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI; Division of Pediatric Psychology, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI.
Jennifer
J
Butcher
Division of Cardiology, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI; Department of Pediatrics and Communicable Diseases, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI.
Michael
M
Gaies
Division of Cardiology, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI; Department of Pediatrics and Communicable Diseases, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI.
Cynthia
C
Smith
Division of Medicine Critical Care, Boston Children's Hospital and Harvard Medical School, Boston, MA.
Jamin L
JL
Alexander
Department of Cardiology, Boston Children's Hospital and Harvard Medical School, Boston, MA; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA.
David
D
Wypij
Division of Medicine Critical Care, Boston Children's Hospital and Harvard Medical School, Boston, MA.
Michael S D
MS
Agus
D000465:Algorithms; D001786:Blood Glucose; D002315:Cardiopulmonary Bypass / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006330:Heart Defects, Congenital / Q000601:surgery*; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000517:prevention & control*; D007223:Infant; D008297:Male; D065886:Neurodevelopmental Disorders / Q000453:epidemiology*; D011182:Postoperative Care; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D016896:Treatment Outcome
D001786:Blood Glucose
cardiac; cardiac surgery; glycemic control/blood glucose; hypoglycemia; neurodevelopment