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In this double-blind randomized controlled trial from northern India, Nim and Adrianne review whether early hydrocortisone reduces 14-day all-cause mortality in preterm infants with fluid-refractory shock. The primary outcome showed no statistically significant difference between groups, though an 11 percent absolute reduction in mortality in the hydrocortisone group raised clinical interest. A major limitation was the high rate of open-label steroid crossover, with over 70 percent of both groups ultimately receiving hydrocortisone. The study highlights the difficulty of achieving equipoise when clinicians already believe strongly in a therapy, and raises important questions about study design in neonatal shock research.
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Early hydrocortisone verses placebo in neonatal shock- a double blind Randomized controlled trial. Dudeja S, Saini SS, Sundaram V, Dutta S, Sachdeva N, Kumar P.J Perinatol. 2025 Mar;45(3):342-349. doi: 10.1038/s41372-025-02222-3. Epub 2025 Feb 13.PMID: 39948354 Clinical Trial.
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