Evidence map›Paper›PMID 37019334›Full record

Trial reportThe Journal of pediatrics2023

Safety of High Dose Erythropoietin Used with Therapeutic Hypothermia as Treatment for Newborn Hypoxic-Ischemic Encephalopathy: Secondary Analysis of the HEAL Randomized Controlled Trial.

Sandra E Juul, Bryan A Comstock, Marie-Coralie Cornet, Fernando F Gonzalez, Dennis E Mayock, Hannah C Glass, Michael D Schreiber, Patrick J Heagerty, Yvonne W Wu

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of pediatrics, 2023. 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 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
9.3field-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.

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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
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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

9 authors at 3 institutions in 1 country.

Sandra E JuulDepartment of Pediatrics, University of Washington School of Medicine, Seattle, WA. Electronic address: sjuul@uw.edu.
Bryan A ComstockDepartment of Biostatistics, University of Washington, Seattle, WA.
Marie-Coralie CornetDepartment of Pediatrics, University of California, San Francisco, San Francisco, CA.
Fernando F GonzalezDepartment of Pediatrics, University of California, San Francisco, San Francisco, CA.
Dennis E MayockDepartment of Pediatrics, University of Washington School of Medicine, Seattle, WA.
Hannah C GlassDepartment of Pediatrics, University of California, San Francisco, San Francisco, CA; Department of Neurology, University of California, San Francisco, San Francisco, CA.
Michael D SchreiberDepartment of Pediatrics, The University of Chicago, Chicago, IL.
Patrick J HeagertyDepartment of Biostatistics, University of Washington, Seattle, WA.
Yvonne W WuDepartment of Pediatrics, University of California, San Francisco, San Francisco, CA; Department of Neurology, University of California, San Francisco, San Francisco, CA.
University of California, San Francisco · USUniversity of Washington · USUniversity of Chicago · 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
Maternal Chorioamnionitis and Hypoxic-Ischemic Encephalopathy: The MATCH StudyK23HD109684 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Marie Cornet · 2022 to 2026
$867k
NCATS NIH HHS UL1 TR002319NICHD NIH HHS K23 HD109684NICHD NIH HHS P50 HD103524NINDS NIH HHS U01 NS092553NINDS NIH HHS U01 NS092764
6 · The paper itself

Abstract

objectiveTo assess whether high dose erythropoietin (Epo) treatment of cooled infants with neonatal hypoxic ischemic encephalopathy results in a higher risk of prespecified serious adverse events (SAEs). STUDY

designFive hundred infants born at ≥36 weeks of gestation with moderate or severe hypoxic ischemic encephalopathy undergoing therapeutic hypothermia were randomized to Epo or placebo on days 1, 2, 3, 4, and 7. Pretreatment and posttreatment SAEs were compared with adjusted generalized linear models, with posttreatment models adjusted for the presence of a pretreatment SAE. Clinical risk factors and potential mechanisms for SAEs were also examined.

resultsThe rate of experiencing at least one posttreatment SAE did not significantly differ between groups (adjusted relative risk [aRR], 95% CI: 1.17, 0.92-1.49); however, posttreatment thrombosis was identified more often in the Epo group (n = 6, 2.3%) than the placebo group (n = 1, 0.4%; aRR, 95% CI: 5.09, 1.32-19.64). The rate of posttreatment intracranial hemorrhage identified at the treatment sites by either ultrasound or magnetic resonance imaging was slightly elevated in the Epo group (n = 61, 24%) but not significantly different from the placebo group (n = 46, 19%; aRR, 95% CI: 1.21, 0.85, 1.72).

conclusionsA small increased risk of major thrombotic events was identified in the Epo treatment group.

trial registrationNCT02811263.

Indexed as

ErythropoietinHypothermia, InducedHypoxia-Ischemia, BrainCold TemperatureHumansInfantInfant, NewbornErythropoietin

Identifiers

PMID37019334
PMCPMC10760810
OpenAlexW4362575755

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

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.