Kovács, Kata and Szakmár, Enikő and Dobi, Marianna and Varga, Zsuzsanna and Méder, Ünőke and Szabó, Attila and McNamara, Patrick J. and Szabó, Miklós and Jermendy, Ágnes (2025) Neurodevelopmental outcome in infants with neonatal encephalopathy receiving hydrocortisone during therapeutic hypothermia: follow-up of the extended-CORTISoL trial. JOURNAL OF PERINATOLOGY. ISSN 0743-8346 (In Press)
|
Text
KovacsJPerinat2025.pdf - Published Version Available under License Creative Commons Attribution. Download (551kB) | Preview |
Abstract
Objective To investigate neurodevelopmental outcome after hydrocortisone (HC) supplementation in infants with neonatal encephalopathy (NE) and hypotension. Study design 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. Result 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). Conclusion 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. Clinical trial registration 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.
| Item Type: | Article |
|---|---|
| Additional Information: | KK was awarded a fellowship by the Hungarian Academy of Sciences to support researchers raising children, as well as the Márer Vera Award. She was also supported by the Hungarian Scientific Research Fund’s Postdoctoral Excellence Program (OTKA PD 142288), as well as the National Talent Program’s Scholarship for Young Talents of the Nation (NTP-NFTÖ-22-B-0068). AJ was supported by the TKP2021-EGA25 grant of the National Research, Development and Innovation Office, Hungary. Project no. RRF- 2.3.1-21-2022-00011, titled National Laboratory of Translational Neuroscience has been implemented with the support provided by the Recovery and Resilience Facility of the European Union within the framework of Programme Széchenyi Plan Plus. The funding agencies had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. Open access funding provided by Semmelweis University. |
| Subjects: | R Medicine / orvostudomány > R1 Medicine (General) / orvostudomány általában |
| SWORD Depositor: | MTMT SWORD |
| Depositing User: | MTMT SWORD |
| Date Deposited: | 24 Sep 2025 10:03 |
| Last Modified: | 24 Sep 2025 10:03 |
| URI: | https://real.mtak.hu/id/eprint/225126 |
Actions (login required)
 |
Edit Item |
