Methylprednisolone for Heart Surgery in Infants — A Randomized, Controlled Trial

This multicenter, randomized, placebo-controlled trial (STRESS) evaluated the prophylactic use of methylprednisolone in infants (<1 year) undergoing heart surgery with cardiopulmonary bypass. A total of 1263 infants were randomized across 24 U.S. sites, with 1200 receiving either methylprednisolone (599) or placebo (601) infused into bypass pump-priming fluid. The primary endpoint, a ranked composite of death, transplantation, major complications, or length of hospital stay, showed no statistically significant difference (adjusted OR: 0.86; 95% CI: 0.71–1.05; P=0.14). Secondary analyses suggested a modest benefit (unadjusted OR: 0.82; win ratio: 1.15), and methylprednisolone was associated with reduced reoperations for bleeding (OR: 0.34; 95% CI: 0.14–0.81). However, it increased postoperative hyperglycemia requiring insulin (19.0% vs. 6.7%; P<0.001). Subgroup trends favored methylprednisolone in lower-complexity procedures and longer bypass durations. The study concludes that methylprednisolone does not significantly reduce adverse outcomes overall and increases risk of postoperative hyperglycemia, though registry-based trial design enabled efficient, large-scale pediatric enrollment.

This multicenter, randomized, placebo-controlled trial (STRESS) evaluated the prophylactic use of methylprednisolone in infants (<1 year) undergoing heart surgery with cardiopulmonary bypass. A total of 1263 infants were randomized across 24 U.S. sites, with 1200 receiving either methylprednisolone (599) or placebo (601) infused into bypass pump-priming fluid. The primary endpoint, a ranked composite of death, transplantation, major complications, or length of hospital stay, showed no statistically significant difference (adjusted OR: 0.86; 95% CI: 0.71–1.05; P=0.14). Secondary analyses suggested a modest benefit (unadjusted OR: 0.82; win ratio: 1.15), and methylprednisolone was associated with reduced reoperations for bleeding (OR: 0.34; 95% CI: 0.14–0.81). However, it increased postoperative hyperglycemia requiring insulin (19.0% vs. 6.7%; P<0.001). Subgroup trends favored methylprednisolone in lower-complexity procedures and longer bypass durations. The study concludes that methylprednisolone does not significantly reduce adverse outcomes overall and increases risk of postoperative hyperglycemia, though registry-based trial design enabled efficient, large-scale pediatric enrollment.