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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Congenital Heart Disease in Children, Neuroprotection

In brief

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.

Key facts

Study ID

NCT04217421

Run by

dr. M.J.N.L. Benders

People needed

236

Starts

2020-02-14

Expected to finish

2028-12-31

Last updated by the study team

2024-05-16

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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".

Where it is running

• University Medical Center Groningen (UMCG) — Groningen, Netherlands (enrolling)
• Erasmus Medical Center Rotterdam (Erasmus MC) — Rotterdam, Netherlands (enrolling)
• University Medical Center Utrecht (UMC Utrecht) — Utrecht, Netherlands (enrolling)
• Radboud University Medical Center Nijmegen (Radboudumc) — Nijmegen, Netherlands

Full record on ClinicalTrials.gov

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