Evidence map›Paper›PMID 39580594›Full record

Trial reportPediatric research2025

Pro-inflammatory biomarkers and long term neurological outcomes in hypothermia plus melatonin treated asphyxiated newborns. A preliminary approach.

Antonio Jerez Calero, Francisco Contreras Chova, Ángela Benítez Feliponi, Hatim Azaryah, Jose Antonio Hurtado Suazo, M Fernanda Moreno Galdó, Antonio Molina Carballo

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Pediatric research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Observational
  3. Article
  4. Article
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

7 authors.

Antonio Jerez CaleroInstituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain. aejerezc@ugr.es.
Francisco Contreras ChovaDepartment of Pediatrics, Clínico San Cecilio University Hospital, Granada, Spain.
Ángela Benítez FeliponiDepartment of Pediatrics, Faculty of Medicine. University of Granada, Granada, Spain.
Hatim AzaryahDepartment of Pediatrics, Faculty of Medicine. University of Granada, Granada, Spain.
Jose Antonio Hurtado SuazoDepartment of Pediatrics, Virgen de las Nieves University Hospital, Granada, Spain.
M Fernanda Moreno GaldóDepartment of Pediatrics, Virgen de las Nieves University Hospital, Granada, Spain.
Antonio Molina CarballoInstituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.

Funding

Spanish Ministry of Health
6 · The paper itself

Abstract

objectiveTo evaluate serum neuronal and inflammatory biomarkers in asphyxiated newborns treated with hypothermia alone or hypothermia plus melatonin, and whether biomarkers correlate with neurodevelopmental outcomes.

designA pilot multicentre, randomized, controlled, double blind clinical trial. 25 newborns were recruited. Neonatal neural biomarkers were measured in serum samples at hospital admission (T0), 24 h (T1), 72 hours (T2) and 7-10 days of age (T3). Neurodevelopmental scales were performed at 6 and 18 months. Treated patients received a daily dose of intravenous melatonin, for 3 days.

resultsIn melatonin-treated group, lower plasma levels of GM-CSF, IL-2 and IL-13 at T1 were measured vs placebo-group. We also corroborated, at T2, lower concentrations of GM-CSF, as well as IL-7 and IL-13 at T3. Throughout the study period, we found a significant decrease in GM-CSF concentrations in the treatment group. We have also observed sustained decrease over time of GM-CSF and inflammatory cytokines IL-2, IL-7 and IL-13 correlates with better neurodevelopmental outcomes at 6 and 18 months.

conclusionsIn neonates affected by hypoxic-ischemic encephalopathy, the addition of iv melatonin to hypothermia therapy affects plasma biomarker concentration in the first week of life, with a high correlation with long-term neurological prognosis. IMPACT: Several plasma cytokines act as inflammatory mediators and biomarkers of hypoxia-ischemia-acquired neonatal brain damage. In animal research, melatonin has been shown to be a safe substance with proven anti-inflammatory and neuroprotective effects. Findings from our clinical trial show that melatonin affects plasma inflammatory biomarker concentration within the first week of life. This effect may be related to long-term neurological prognosis. To date, this is the only clinical trial in human infants including asphyxiated neonates treated with hypothermia and intravenous melatonin. Our study could help design future larger, well-designed clinical trials to clarify its effects in asphyxiated neonates.

Indexed as

Asphyxia NeonatorumHypothermia, InducedHypoxia-Ischemia, BrainInflammation MediatorsMelatoninBiomarkersCytokinesDouble-Blind MethodFemaleGranulocyte-Macrophage Colony-Stimulating FactorHumansInfantInfant, NewbornInflammationMalePilot ProjectsBiomarkersCytokinesGranulocyte-Macrophage Colony-Stimulating FactorInflammation MediatorsMelatonin

Identifiers

PMID39580594

What OpenQuestion holds

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Registered trials

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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.