Evidence map›Paper›PMID 29514165›Full record

ArticleNeonatology2018

High-Dose Erythropoietin for Asphyxia and Encephalopathy (HEAL): A Randomized Controlled Trial - Background, Aims, and Study Protocol.

Sandra E Juul, Bryan A Comstock, Patrick J Heagerty, Dennis E Mayock, Amy M Goodman, Stephanie Hauge, Fernando Gonzalez, Yvonne W Wu

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Neonatology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02811263 (High-dose Erythropoietin for Asphyxia and Encephalopathy), which is not on this map. Cited by 79 papers.

0numbers the graph read from it
0cells of the map it votes in
79citing 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.

NCT02811263 phase3completednot on this map

High-dose Erythropoietin for Asphyxia and Encephalopathy

TypeinterventionalSponsorUniversity of California, San FranciscoRan2017 to 2022Enrolled500ConditionsNeonatal Encephalopathy, Birth AsphyxiaArmsNormal saline placebo, Erythropoietin
3 · Its place in the literature

Who cites it

79 citing papers in PubMed.

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  17. Vitamin D as an Adjuvant Therapy in Neonatal Hypoxia: Is it Beneficial?Endocrine, metabolic & immune disorders drug targets · 2019
    Trial
  18. Review
  19. Observational
  20. Comparison of the prognosis of asphyxiated infants receiving hypothermia therapy with those receiving erythropoietin: a prospective cohort study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Article

19 more citing papers are in PubMed but not listed here.

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

8 authors.

Sandra E JuulDepartment of Pediatrics, Division of Neonatology, University of Washington, Seattle, Washington, USA.
Bryan A ComstockDepartment of Biostatistics, University of Washington, Seattle, Washington, USA.
Patrick J HeagertyDepartment of Biostatistics, University of Washington, Seattle, Washington, USA.
Dennis E MayockDepartment of Pediatrics, Division of Neonatology, University of Washington, Seattle, Washington, USA.
Amy M GoodmanDepartment of Neurology, Division of Child Neurology, University of California, San Francisco, California, USA.
Stephanie HaugeDepartment of Pediatrics, Division of Neonatology, University of Washington, Seattle, Washington, USA.
Fernando GonzalezDepartment of Neurology, Division of Child Neurology, University of California, San Francisco, California, USA.
Yvonne W WuDepartment of Neurology, Division of Child Neurology, University of California, San Francisco, California, USA.

Funding

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
High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) DCCU01NS092553 · NINDS · UNIVERSITY OF WASHINGTON · PI HEAGERTY, PATRICK J · 2016 to 2020
$1.7M
NINDS NIH HHS U01 NS092553NINDS NIH HHS U01 NS092764
6 · The paper itself

Abstract

backgroundHypoxic-ischemic encephalopathy (HIE) remains an important cause of neonatal death and frequently leads to significant long-term disability in survivors. Therapeutic hypothermia, while beneficial, still leaves many treated infants with lifelong disabilities. Adjunctive therapies are needed, and erythropoietin (Epo) has the potential to provide additional neuroprotection.

objectivesThe aim of this study was to review the current incidence, mechanism of injury, and sequelae of HIE, and to describe a new phase III randomized, placebo-controlled trial of Epo neuroprotection in term and near-term infants with moderate to severe HIE treated with therapeutic hypothermia.

methodsThis article presents an overview of HIE, neuroprotective functions of Epo, and the design of a double-blind, placebo-controlled, multicenter trial of high-dose Epo administration, enrolling 500 neonates ≥36 weeks of gestation with moderate or severe HIE diagnosed by clinical criteria. RESULTS AND

conclusionsEpo has robust neuroprotective effects in preclinical studies, and phase I/II trials suggest that multiple high doses of Epo may provide neuroprotection against brain injury in term infants. The High Dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) Trial will evaluate whether high-dose Epo reduces the combined outcome of death or neurodevelopmental disability when given in conjunction with hypothermia to newborns with moderate/severe HIE.

Indexed as

AsphyxiaClinical Trials, Phase III as TopicDouble-Blind MethodErythropoietinFemaleHumansHypothermia, InducedHypoxia-Ischemia, BrainInfant, NewbornLogistic ModelsMaleMulticenter Studies as TopicNeuroprotectionNeuroprotective AgentsRandomized Controlled Trials as TopicErythropoietinNeuroprotective AgentsHypoxia-ischemiaNeonatal encephalopathyNeuroprotectionTherapeutic hypothermia

Identifiers

PMID29514165
PMCPMC5980685

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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.