Abstract 4144734: Effect of Methylprednisolone on Inflammation and Clinical Outcomes in Neonates Undergoing Cardiac Surgery: A Randomized Controlled Trial

Background: Corticosteroids are widely used in neonatal cardiac surgery for anti-inflammatory purposes. Previous research has demonstrated that perioperative use of methylprednisolone (MP) leads to a reduced inflammatory response. Nevertheless, the benefit of MP for postoperative clinical outcomes is controversial, especially in neonates. This study aimed to evaluate the effect of MP on postoperative inflammation and outcomes in neonatal cardiac surgery with cardiopulmonary bypass (CPB). Methods: From September 2020 to August 2023, 86 neonates who underwent cardiac surgery with CPB were enrolled in this double-blind randomized controlled trial. After anesthesia induction, the MP group received a single dose of 30 mg/kg MP, and the placebo group received an equal volume of saline solution. The primary endpoints were plasma concentrations of interleukins (IL-6, IL-8, and IL-10) and D-dimer. Composite outcomes included death, respiratory infection, cardiac arrest, the need for extracorporeal membrane oxygenation, acute kidney injury, low cardiac output syndrome, and prolonged mechanical ventilation. Results: MP did not reduce the odds of a composite outcome (OR, 1.208; 95% CI, 0.515-2.832; p = 0.664), which occurred in 25 patients (58.1%) in the MP group and 23 patients (53.5%) in the control group. Consistent with the observed anti-inflammatory effects, MP resulted in significantly lower concentrations of proinflammatory cytokines (IL-6 and IL-8) and higher concentrations of an anti-inflammatory cytokine (IL-10). The postoperative vasoactive inotropic score (VIS) was significantly lower, while postoperative procalcitonin and nadir mixed venous oxygen saturation (SvO 2 ) during the first 24 h were distinctly greater in the MP group. No differences in postoperative D-dimer, blood glucose or insulin administration were detected between the two groups. Conclusion: Compared with placebo, the prophylactic administration of 30 mg/kg MP to neonates who underwent cardiac surgery with CPB did not improve clinical outcomes. However, a decreased inflammatory response was detected.