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Randomized Controlled Trial
. 2025 Mar;45(3):342-349.
doi: 10.1038/s41372-025-02222-3. Epub 2025 Feb 13.

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

Sankalp Dudeja  1 , Shiv Sajan Saini  2 , Venkataseshan Sundaram  1 , Sourabh Dutta  1 , Naresh Sachdeva  3 , Praveen Kumar  1
Affiliations
Randomized Controlled Trial

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

Sankalp Dudeja et al. J Perinatol. 2025 Mar.

Abstract

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.

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Conflict of interest statement

Competing interests: In this investigator-initiated, non-funded study, the authors have no relevant financial or non-financial interests to disclose. Shiv Sajan Saini wrote the first draft of the manuscript. No honorarium, grant, or other form of payment was given to anyone to produce the manuscript. Ethics approval and consent to participate: The Institute’s Ethics Committee approved the study protocol (Reference no. MK/2896/DM dated 08.08.2016). The study was prospectively registered with the Clinical Trail Registry of India (ref. no. CTRI/2016/09/007276). The study was performed in accordance with the Declaration of Helsinki.

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