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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

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.

• Patient considered "moribund".

• Decision for "comfort care only".