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

What this Trial Is About

Neurodevelopmental problems caused by delayed brain development and brain injury are common in children with critical congenital heart disease (CCHD). These children often face long-term motor, cognitive, and behavioral challenges due to brain injury occurring early after birth and around the time of heart surgery. Researchers are studying whether the drug allopurinol, which reduces harmful oxygen radicals, can protect the brain and heart in these children during this vulnerable period. The study compares allopurinol with a placebo in newborns diagnosed with CCHD who need heart surgery using cardiopulmonary bypass within their first month of life. Allopurinol or placebo is given multiple times: early after birth, before surgery, during surgery, and after surgery, depending on when the diagnosis is made. The goal is to see if allopurinol can reduce brain injury and protect heart function during these critical times. Participants will undergo brain MRI scans before and after surgery to assess brain injury, as well as monitoring of brain function and oxygen levels at specific times around birth and surgery. Researchers will also evaluate motor skills and neurodevelopment at 3 months and 24 months of age. The study tracks outcomes including brain injury severity, heart function, seizures, quality of life, and mortality up to one month after surgery. This comprehensive monitoring aims to understand allopurinol's effects on brain and heart health in these newborns.

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