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

RecruitingPhase 3Ages any - 1 MonthAlldr. M.J.N.L. Benders
NCT04217421 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Neonates with a prenatally or postnatally confirmed diagnosis of CCHD requiring (anticipated) cardiac surgery with CPB within the first 4 weeks of life. * Informed consent provided by both parents. Exclusion Criteria: * Inability to enroll the patient before the start of delivery in case of prenatal diagnosis, or 24 hours before surgery in case of postnatal diagnosis. * Doubt whether the aortic arch anomaly before birth requires cardiac surgery with CPB in the neonatal period. * Gestational age below 36 weeks and/or birth weight less than 2000 gram. * Surgery not requiring cardiopulmonary bypass. * Decision for "comfort care only".
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What it tests

  • Allopurinol
  • Mannitol
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Where

4 sites
University Medical Center Groningen (UMCG)
Groningen, Netherlands
Radboud University Medical Center Nijmegen (Radboudumc)
Nijmegen, Netherlands
Erasmus Medical Center Rotterdam (Erasmus MC)
Rotterdam, Netherlands
University Medical Center Utrecht (UMC Utrecht)
Utrecht, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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