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
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