Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial

Summary

The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g. The main questions it aims to answer are: * Does the early use of hydrocortisone help solve shock in preterm infants under 1500 g faster than the standard treatment? * Does the early use of hydrocortisone help prevent death within the first seven days of presentation of shock in comparison to premature infants who receive regular treatment? Researchers will compare the early use of hydrocortisone plus the standard treatment to solve shock against just standard treatment. Participants will: * Be randomized to receive standard treatment for shock according to their neonatologist or this standard treatment plus hydrocortisone as soon as the diagnosis is done and treatment is started. * Be followed either until shock is solved or if they present death due to this event of shock.

Timeline

Start

2025-02-01

Primary completion

2026-06-30

Completion

2026-07-30

Publications

• Background Patra K, Greene MM, Silvestri JM. Neurodevelopmental impact of hydrocortisone exposure in extremely low birth weight infants: outcomes at 1 and 2 years. J Perinatol. 2015 Jan;35(1):77-81. doi: 10.1038/jp.2014.133. Epub 2014 Jul 31.
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• Background Kumbhat N, Noori S. Corticosteroids for Neonatal Hypotension. Clin Perinatol. 2020 Sep;47(3):549-562. doi: 10.1016/j.clp.2020.05.015. Epub 2020 May 22.
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• Background Dudeja S, Saini SS, Sundaram V, Dutta S, Sachdeva N, Kumar P. Early hydrocortisone verses placebo in neonatal shock- a double blind Randomized controlled trial. J Perinatol. 2025 Mar;45(3):342-349. doi: 10.1038/s41372-025-02222-3. Epub 2025 Feb 13.
• Background Watterberg KL, Shaffer ML, Mishefske MJ, Leach CL, Mammel MC, Couser RJ, Abbasi S, Cole CH, Aucott SW, Thilo EH, Rozycki HJ, Lacy CB. Growth and neurodevelopmental outcomes after early low-dose hydrocortisone treatment in extremely low birth weight infants. Pediatrics. 2007 Jul;120(1):40-8. doi: 10.1542/peds.2006-3158.
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