Evidence map›Paper›PMID 36470964›Full record

Trial reportPediatric research2023

Risk of seizures in neonates with hypoxic-ischemic encephalopathy receiving hypothermia plus erythropoietin or placebo.

Hannah C Glass, Courtney J Wusthoff, Bryan A Comstock, Adam L Numis, Fernando F Gonzalez, Nathalie Maitre, Shavonne L Massey, Dennis E Mayock, Ulrike Mietzsch, Niranjana Natarajan and 8 more

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatric research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
8.4field-weighted citation impact, top 2% of its field
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

14 citing papers in PubMed, 22 citations in OpenAlex.

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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

18 authors at 11 institutions in 1 country.

Hannah C GlassDepartment of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA, USA. Hannah.Glass@ucsf.edu.
Courtney J WusthoffDepartment of Neurology, Stanford University, Palo Alto, CA, USA.
Bryan A ComstockDepartment Biostatistics, University of Washington, Seattle, WA, USA.
Adam L NumisDepartment of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA, USA.
Fernando F GonzalezDepartment of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA, USA.
Nathalie MaitreDepartment of Pediatrics, and Emory + Children's Pediatric Institute, Emory University, Atlanta, GA, USA.
Shavonne L MasseyDepartments of Neurology and Pediatrics, Children's Hospital of Philadelphia and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Dennis E MayockDepartment of Pediatrics, Division of Neonatology, University of Washington School of Medicine, Seattle Children's Hospital, Seattle, WA, USA.
Ulrike MietzschDepartment of Pediatrics, Division of Neonatology, University of Washington School of Medicine, Seattle Children's Hospital, Seattle, WA, USA.
Niranjana NatarajanDepartment of Neurology, University of Washington School of Medicine, Seattle, WA, USA.
Gregory M SokolDepartment of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.
Sonia L BonifacioDivision of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital Stanford, Palo Alto, CA, USA.
Krisa P Van MeursDivision of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital Stanford, Palo Alto, CA, USA.
Cameron ThomasDepartment of Pediatrics, University of Cincinnati, Cincinnati, OH, USA.
Kaashif A AhmadPediatrix Neonatology of San Antonio, San Antonio, TX, USA.
Patrick J HeagertyDepartment Biostatistics, University of Washington, Seattle, WA, USA.
Sandra E JuulDepartment of Pediatrics, Division of Neonatology, University of Washington School of Medicine, Seattle Children's Hospital, Seattle, WA, USA.
Yvonne W WuDepartment of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA, USA.
University of Washington · USSeattle Children's Hospital · USStanford University · USUCSF Benioff Children's Hospital · USUniversity of California, San Francisco · USChildren's Hospital of Philadelphia · USEmory University · USIndiana University School of MedicinePalo Alto University · USUniversity of Cincinnati · USUrology San Antonio · US

Funding

Transform Dissemination and Implementation Science in CTSA ProgramsUL1TR002319 · NCATS · UNIVERSITY OF WASHINGTON · PI John K. Amory · 2017 to 2026
$100.0M
High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) CCCU01NS092764 · NINDS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JUUL, SANDRA E, WU, YVONNE W · 2016 to 2020
$12.7M
Mechanisms of Brain Dysmorphology in MN1 C-Terminal Truncation Syndrome, a Novel Intellectual Developmental Disability Disorder P50HD103524 · NICHD · UNIVERSITY OF WASHINGTON · PI DANIEL DOHERTY · 2020 to 2026
$9.9M
High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) DCCU01NS092553 · NINDS · UNIVERSITY OF WASHINGTON · PI HEAGERTY, PATRICK J · 2016 to 2020
$1.7M
HEAL - EEG - Neurophysiologic measures of Epo treatment for hypoxic-ischemic encephalopathy (HIE)R01NS104322 · NINDS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GLASS, HANNAH CRANLEY · 2018 to 2021
$1.5M
Evaluating the Role of Inflammation in Neonatal EpileptogenesisK23NS105918 · NINDS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI NUMIS, ADAM LAWRENCE · 2019 to 2023
$1.1M
NCATS NIH HHS UL1 TR002319NICHD NIH HHS P50 HD103524NINDS NIH HHS K23 NS105918NINDS NIH HHS R01 NS104322NINDS NIH HHS U01 NS092553NINDS NIH HHS U01 NS092764
6 · The paper itself

Abstract

backgroundAn ancillary study of the High-Dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial for neonates with hypoxic-ischemic encephalopathy (HIE) and treated with therapeutic hypothermia examined the hypothesis that neonates randomized to receive erythropoietin (Epo) would have a lower seizure risk and burden compared with neonates who received placebo.

methodsElectroencephalograms (EEGs) from 7/17 HEAL trial centers were reviewed. Seizure presence was compared across treatment groups using a logistic regression model adjusting for treatment, HIE severity, center, and seizure burden prior to the first dose. Among neonates with seizures, differences across treatment groups in median maximal hourly seizure burden were assessed using adjusted quantile regression models.

resultsForty-six of 150 (31%) neonates had EEG seizures (31% in Epo vs 30% in placebo, p = 0.96). Maximal hourly seizure burden after the study drug was not significantly different between groups (median 11.4 for Epo, IQR: 5.6, 18.1 vs median 9.7, IQR: 4.9, 21.0 min/h for placebo).

conclusionIn neonates with HIE treated with hypothermia who were randomized to Epo or placebo, we found no meaningful between-group difference in seizure risk or burden. These findings are consistent with overall trial results, which do not support Epo use for neonates with HIE undergoing therapeutic hypothermia. IMPACT: In the HEAL trial of erythropoietin (Epo) vs placebo for neonates with encephalopathy presumed due to hypoxic-ischemic encephalopathy (HIE) who were also treated with therapeutic hypothermia, electrographic seizures were detected in 31%, which is lower than most prior studies. Epo did not reduce the proportion of neonates with acute provoked seizures (31% in Epo vs 30% in placebo) or maximal hourly seizure burden after the study drug (median 11.4, IQR 5.6, 18.1 for Epo vs median 9.7, IQR 4.9, 21.0 min/h for placebo). There was no anti- or pro-convulsant effect of Epo when combined with therapeutic hypothermia for HIE.

Indexed as

ErythropoietinHypothermiaHypothermia, InducedHypoxia-Ischemia, BrainAsphyxiaHumansInfant, NewbornSeizuresErythropoietin

Identifiers

PMID36470964
PMCPMC10239788
OpenAlexW4310955238

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.