Study of Nitric Oxide Gas During Newborn Heart Surgery to Prevent Acute Kidney Injury

What this Trial Is About

Acute kidney injury AKI is a common and serious complication in newborns undergoing heart surgery for congenital heart defects CHD, affecting up to 60% of high-risk patients. This condition contributes significantly to both short- and long-term health problems and mortality. Current treatments have not successfully prevented this kidney function decline after surgery, so researchers are studying whether nitric oxide administered during cardiopulmonary bypass CPB can reduce the risk of AKI. In this study, newborns undergoing heart surgery with CPB will be randomly assigned to receive either nitric oxide gas at 20 parts per million through the oxygenator of the CPB circuit or standard care without nitric oxide. This intervention is given only during the surgery. The study compares these two groups to evaluate the potential benefit of nitric oxide in protecting kidney function. Participants will be monitored during and after surgery, with assessments focused on signs of AKI within 72 hours, including biomarkers like NGAL, KIM-1, IL-18, L-FABP, and urinary nitrite. Kidney function measured by glomerular filtration rate GFR and heart function indicators such as low cardiac output within 48 hours will also be evaluated. The study includes careful monitoring for safety and outcomes up to 3 years of age, as all participants are newborns undergoing surgical treatment for CHD.

NO During CPB in Neonates to Reduce Risk of AKI