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Study identifier: NCT04217421 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Congenital Heart Disease in Children · Neuroprotection  ·  Sponsor: dr. M.J.N.L. Benders

PhasePhase 3
Planned participants236
Who can joinAll sexes, N/A to 1 Month
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Manon JNL Benders, Prof. MD PhD  ·  0031887554545  ·  m.benders@umcutrecht.nl

Maaike Nijman, MD  ·  m.nijman@umcutrecht.nl

Always discuss trial participation with your own doctor first.

Locations (4)

University Medical Center Groningen (UMCG)Groningen, NetherlandsRecruiting
Radboud University Medical Center Nijmegen (Radboudumc)Nijmegen, NetherlandsActive Not Recruiting
Erasmus Medical Center Rotterdam (Erasmus MC)Rotterdam, NetherlandsRecruiting
University Medical Center Utrecht (UMC Utrecht)Utrecht, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT04217421