Objective <p>To compare early hydrocortisone (initiated along with vasoactive therapy) <i>vs</i>. placebo for all-cause mortality within next 14 days among neonates with fluid-refractory shock.</p> Study design <p>Neonates with fluid-refractory shock were randomly assigned to receive hydrocortisone or saline placebo alongside vasoactive drugs. If they developed catecholamine-resistant shock, the study drug was replaced with open-label hydrocortisone.</p> Result <p>Eighty-four neonates were randomized (early hydrocortisone=43 and placebo=41). Median gestational age of our cohort (<i>n</i> = 84) was 30.3 weeks [interquartile range (IQR): 27.7, 32.5] and median birth weight was 1148 grams (IQR: 860, 1419). The 14-day all-cause mortality was comparable between early hydrocortisone and placebo groups [OR 0.53 (95% CI 0.19, 1.52)]. Both groups had similar duration of vasoactive drugs and vasoactive-inotrope scores, incidence of adverse effects of hydrocortisone and incidence of medium-term complications.</p> Conclusion <p>We did not observe a significant reduction in 14-day mortality with early hydrocortisone compared to placebo in fluid-refractory neonatal shock.</p>

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Early hydrocortisone verses placebo in neonatal shock- a double blind Randomized controlled trial

  • Sankalp Dudeja,
  • Shiv Sajan Saini,
  • Venkataseshan Sundaram,
  • Sourabh Dutta,
  • Naresh Sachdeva,
  • Praveen Kumar

摘要

Objective

To compare early hydrocortisone (initiated along with vasoactive therapy) vs. placebo for all-cause mortality within next 14 days among neonates with fluid-refractory shock.

Study design

Neonates with fluid-refractory shock were randomly assigned to receive hydrocortisone or saline placebo alongside vasoactive drugs. If they developed catecholamine-resistant shock, the study drug was replaced with open-label hydrocortisone.

Result

Eighty-four neonates were randomized (early hydrocortisone=43 and placebo=41). Median gestational age of our cohort (n = 84) was 30.3 weeks [interquartile range (IQR): 27.7, 32.5] and median birth weight was 1148 grams (IQR: 860, 1419). The 14-day all-cause mortality was comparable between early hydrocortisone and placebo groups [OR 0.53 (95% CI 0.19, 1.52)]. Both groups had similar duration of vasoactive drugs and vasoactive-inotrope scores, incidence of adverse effects of hydrocortisone and incidence of medium-term complications.

Conclusion

We did not observe a significant reduction in 14-day mortality with early hydrocortisone compared to placebo in fluid-refractory neonatal shock.