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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 1
Sponsordr. M.J.N.L. Benders

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Allopurinol
  • Mannitol

Treatment groups

236 Participants
are divided into 2 treatment groups

Sponsors and collaborators

dr. M.J.N.L. Benders

Lead sponsor

UMC Utrecht

Sponsor institution

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator

University Medical Center Groningen

Collaborator

Erasmus Medical Center

Collaborator

University Medical Center Nijmegen

Collaborator

ACE Pharmaceuticals BV

Collaborator