Prophylactic Methylprednisolone in Neonatal On-Pump Cardiac Surgery

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Background: Corticosteroids are commonly used in neonatal cardiac surgery to reduce inflammation. Previous studies have shown that administering methylprednisolone (MP) during the perioperative period can reduce the inflammatory response. However, the impact of MP on postoperative clinical outcomes in neonates remains unclear. Thus, this study aimed to assess the effects of MP on postoperative inflammation and clinical outcomes in neonates undergoing cardiac surgery involving cardiopulmonary bypass (CPB). Methods: This was a prospective, non-randomized, unblinded, controlled trial in which the clinicians determined treatment assignment. A total of 86 neonates who underwent cardiac surgery with CPB between December 2020 and August 2023 were included. After induction of anesthesia, the MP group received a single dose of 30 mg/kg MP, while the placebo group received an equal volume of saline solution. Primary endpoints were plasma interleukin (IL-6, IL-8, and IL-10) and D-dimer concentrations. Composite outcomes included death, respiratory infection, cardiac arrest, need for extracorporeal membrane oxygenation, acute kidney injury, low cardiac output syndrome, and need for prolonged mechanical ventilation. Results: = 0.664), with 25 patients (58.1%) in the MP group and 23 patients (53.5%) in the placebo group experiencing such outcomes. The MP group also showed a significantly lower postoperative vasoactive-inotropic score and higher postoperative procalcitonin levels and nadir mixed venous oxygen saturation during the first 24 hours. No significant differences in postoperative D-dimer, blood glucose, or insulin administration were observed between the two groups. Conclusions: Prophylactic administration of 30 mg/kg MP in neonates undergoing cardiac surgery with CPB did not result in a statistically significant improvement in clinical outcomes compared with placebo. However, this intervention was associated with a reduction in the inflammatory response. The Clinical Trial Registration: ChiCTR 2000040230, https://www.chictr.org.cn/showproj.html?proj=64716.

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