Overview

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

Status:
Recruiting

Trial end date:
2023-06-01

Target enrollment:

Participant gender:

Summary

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.

Phase:

Phase 3

Details

Lead Sponsor:

dr. M.J.N.L. Benders

Collaborators:

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ACE Pharmaceuticals BV
Erasmus Medical Center
Leiden University Medical Center
University Medical Center Groningen
University Medical Center Nijmegen
VU University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development

Treatments:

Allopurinol
Mannitol