Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass

Neurodevelopmental impairment due to delayed brain development and brain injury is a fundamental problem in children with critical congenital heart disease (CCHD). Significant longterm motor-, cognitive-, and behavioral problems are the result of early postnatally and perioperatively induced brain injury. Allopurinol, a xanthine oxidase inhibitor, prevents the formation of toxic free oxygen radicals, thereby limiting hypoxia-reperfusion damage. Both animal and neonatal studies suggest that administration of allopurinol reduces hypoxic-ischemic brain injury, is cardioprotective, and safe. This study aims to evaluate the efficacy and safety of allopurinol administered early postnatally and perioperatively in children with a CCHD requiring cardiac surgery with cardiopulmonary bypass.

NCT Number	NCT04217421
Lead Sponsor	dr. M.J.N.L. Benders Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, University Medical Center Groningen, Erasmus Medical Center, University Medical Center Nijmegen, ACE Pharmaceuticals BV
Conditions	Congenital Heart Disease in Children, Neuroprotection
Enrollment	236 participants
Start Date	2020-02-14
Primary Completion	2026-10-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-05-16