This multi-center prospective study will validate the RLS as a tool to predict early and mid-term outcomes for five common congenital cardiac operations. The RLS study will develop the first validated tool for measurement of residual lesions following congenital heart surgery. The proposed project will also lay the groundwork for future projects, facilitating continuous quality improvement in congenital heart surgery.
This is a prospective, randomized, double blind, placebo controlled study of intraoperative MP in neonates undergoing CPB. Patients will be allocated to one of the 2 study groups in the ratio of 1:1. The randomization will be stratified by corrective vs. palliative surgery. The Primary Endpoint is a composite morbidity-mortality outcome, evaluated as intention to treat (ITT). Secondary endpoints include inotropic score, incidence of LCOS, fluid balance, ICU stay parameters, levels of inflammatory markers, safety parameters, and neurodevelopmental outcomes at 1 year. A two-sided test with a type I error rate of 0.05 will be used for all endpoints with no adjustments of the p-value for multiple testing.