Neurodevelopmental outcome in infants with neonatal encephalopathy receiving hydrocortisone during therapeutic hypothermia: follow-up of the extended-CORTISoL trial

Kata Kovacs; Eniko Szakmar; Marianna Dobi; Zsuzsanna Varga; Unoke Meder; Attila J Szabo; Patrick J McNamara; Miklos Szabo; Agnes Jermendy

doi:10.1038/s41372-025-02428-5

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Neurodevelopmental outcome in infants with neonatal encephalopathy receiving hydrocortisone during therapeutic hypothermia: follow-up of the extended-CORTISoL trial

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Neurodevelopmental outcome in infants with neonatal encephalopathy receiving hydrocortisone during therapeutic hypothermia: follow-up of the extended-CORTISoL trial

Kata Kovacs, Eniko Szakmar, Marianna Dobi, Zsuzsanna Varga, Unoke Meder, Attila J Szabo, Patrick J McNamara, Miklos Szabo and Agnes Jermendy

Journal of perinatology, Vol.45(12), pp.1788-1794

12/2025

DOI: 10.1038/s41372-025-02428-5

PMCID: PMC12716990

PMID: 40983658

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Abstract

To investigate neurodevelopmental outcome after hydrocortisone (HC) supplementation in infants with neonatal encephalopathy (NE) and hypotension. Fifty-five infants with volume-resistant hypotension during hypothermia were enrolled between 2016 and 2020. Eligible patients were randomly assigned to receive 0.5 mg/kg HC every 6 h or placebo along with standard dopamine treatment. Composite adverse outcome was defined as death or neurodevelopmental impairment, ascertained using the Bayley-II test. At median 20 months of age, death, or severe neurodevelopmental impairment occurred in 40% in the HC group, compared to 18% in the placebo group (p = 0.13). Multiple logistic regression analysis showed that for every 1 mg/kg increase in cumulative HC dose, the odds of adverse cognitive outcome increased by 16% (95% CI 1.01-1.37; p = 0.04). The composite outcomes were similar in the HC-treated and placebo groups, however cumulative HC dose was associated with adverse cognitive outcome in infants with NE and hypotension. Hydrocortisone treatment in systemic low blood pressure during hypothermia in asphyxiated newborns (CORTISoL), ClinicalTrials.gov ID: NCT02700828 https://clinicaltrials.gov/ct2/show/NCT02700828 , date of registration: 2016-02-24.

Details

Title: Subtitle: Neurodevelopmental outcome in infants with neonatal encephalopathy receiving hydrocortisone during therapeutic hypothermia: follow-up of the extended-CORTISoL trial
Creators: Kata Kovacs - Semmelweis University
Eniko Szakmar - Semmelweis University
Marianna Dobi - Semmelweis University
Zsuzsanna Varga - Semmelweis University
Unoke Meder - Semmelweis University
Attila J Szabo - Semmelweis University
Patrick J McNamara - University of Iowa
Miklos Szabo - Semmelweis University
Agnes Jermendy - Semmelweis University
Resource Type: Journal article
Publication Details: Journal of perinatology, Vol.45(12), pp.1788-1794
DOI: 10.1038/s41372-025-02428-5
PMID: 40983658
PMCID: PMC12716990
NLM abbreviation: J Perinatol
ISSN: 0743-8346
eISSN: 1476-5543
Publisher: SPRINGERNATURE
Grant note: OTKA PD 142288 / Országos Tudományos Kutatási Alapprogramok (Hungarian Scientific Research Fund)
Language: English
Electronic publication date: 09/22/2025
Date published: 12/2025
Academic Unit: Stead Family Department of Pediatrics; Neonatology
Record Identifier: 9984966337702771

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