Evidence map›Paper›PMID 40983658›Full record

Trial reportJournal of perinatology : official journal of the California Perinatal Association2025

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

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02700828 (Prospective, Randomized, Double-blind, Cohort Study of Hydrocortisone vs Placebo in Systemic Low Blood Pressure During Hypothermia Treatment in Asphyxiated Newborns), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02700828 phase2 / phase3completednot on this map

Prospective, Randomized, Double-blind, Cohort Study of Hydrocortisone vs Placebo in Systemic Low Blood Pressure During Hypothermia Treatment in Asphyxiated Newborns

TypeinterventionalSponsorSemmelweis UniversityRan2016 to 2022Enrolled32ConditionsHypoxic-Ischemic Encephalopathy, AsphyxiaArmsHydrocortisone, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Kata KovacsDepartment of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary.ORCID http://orcid.org/0000-0002-7115-6147
Eniko SzakmarDepartment of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary.
Marianna DobiDepartment of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary.
Zsuzsanna VargaDepartment of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary.
Unoke MederDepartment of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary.ORCID http://orcid.org/0000-0001-5323-3156
Attila J SzaboDepartment of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary.
Patrick J McNamaraDepartments of Pediatrics and Internal Medicine, University of Iowa, Iowa city, IA, USA.ORCID http://orcid.org/0000-0001-7648-8872
Miklos SzaboDepartment of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary.ORCID http://orcid.org/0000-0003-3317-5619
Agnes JermendyDepartment of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary. jermendy.agnes@semmelweis.hu.ORCID http://orcid.org/0000-0002-2211-7272

Funding

Országos Tudományos Kutatási Alapprogramok (Hungarian Scientific Research Fund) OTKA PD 142288
6 · The paper itself

Abstract

objectiveTo investigate neurodevelopmental outcome after hydrocortisone (HC) supplementation in infants with neonatal encephalopathy (NE) and hypotension. STUDY

designFifty-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.

resultAt 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).

conclusionThe 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 registrationHydrocortisone 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.

Indexed as

Brain DiseasesHydrocortisoneHypotensionHypothermia, InducedNeurodevelopmental DisordersDopamineFemaleFollow-Up StudiesHumansInfantInfant, NewbornLogistic ModelsMaleTreatment OutcomeDopamineHydrocortisone

Identifiers

PMID40983658
PMCPMC12716990

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.