Evidence map›Paper›PMID 39948354›Full record

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

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

Sankalp Dudeja, Shiv Sajan Saini, Venkataseshan Sundaram, Sourabh Dutta, Naresh Sachdeva, Praveen Kumar

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed 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 NCT07248761 (Efficacy of Early Administration of Hydrocortisone in Shock in Preterm Neonates of Less Than 1,500 g), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT07248761 phase4active not recruitingnot on this map

Efficacy of Early Administration of Hydrocortisone in Shock in Preterm Neonates of Less Than 1,500 g

TypeinterventionalSponsorCoordinación de Investigación en Salud, MexicoRan2025 to 2026Enrolled76ConditionsShock, Preterm Birth Complication, Preterm Intraventricular Hemorrhage, Asphyxia PerinatalArmsIntravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Use of hydrocortisone in extremely preterm infants: emphasis on those born least mature.Journal of perinatology : official journal of the California Perinatal Association · 2025
    Review
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

6 authors.

Sankalp DudejaDivision of Neonatology, Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Shiv Sajan SainiDivision of Neonatology, Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India. sajansaini1@gmail.com.ORCID 0000-0003-0865-8053
Venkataseshan SundaramDivision of Neonatology, Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India.ORCID 0000-0002-3135-8115
Sourabh DuttaDivision of Neonatology, Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India.ORCID 0000-0002-5595-8289
Naresh SachdevaDepartment of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Praveen KumarDivision of Neonatology, Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo 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

designNeonates 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.

resultEighty-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.

conclusionWe did not observe a significant reduction in 14-day mortality with early hydrocortisone compared to placebo in fluid-refractory neonatal shock.

Indexed as

Anti-Inflammatory AgentsHydrocortisoneDouble-Blind MethodFemaleGestational AgeHumansInfant, NewbornMaleVasoconstrictor AgentsAnti-Inflammatory AgentsHydrocortisoneVasoconstrictor Agents

Identifiers

PMID39948354

What OpenQuestion holds

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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.