Evidence map›Paper›PMID 25439577›Full record

ArticlePediatric neurology2014

Erythropoietin and hypothermia for hypoxic-ischemic encephalopathy.

Elizabeth E Rogers, Sonia L Bonifacio, Hannah C Glass, Sandra E Juul, Taeun Chang, Dennis E Mayock, David J Durand, Dongli Song, Anthony J Barkovich, Roberta A Ballard and 1 more

Abstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Pediatric neurology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 2 pooled it
–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

39 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  5. Erythropoietin monotherapy in perinatal asphyxia with moderate to severe encephalopathy: a randomized placebo-controlled trial.Journal of perinatology : official journal of the California Perinatal Association · 2017
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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

11 authors.

Elizabeth E RogersDepartment of Neonatology, UCSF Benioff Children's Hospital, San Francisco, California.
Sonia L BonifacioDepartment of Neonatology, UCSF Benioff Children's Hospital, San Francisco, California.
Hannah C GlassDepartment of Neonatology, UCSF Benioff Children's Hospital, San Francisco, California; Department of Neurology, UCSF Benioff Children's Hospital, San Francisco, California.
Sandra E JuulDepartment of Neonatology, University of Washington, Seattle, Washington.
Taeun ChangDepartment of Neurology, Children's National Medical Center, Washington DC.
Dennis E MayockDepartment of Neonatology, University of Washington, Seattle, Washington.
David J DurandDepartment of Neonatology, Children's Hospital & Research Center Oakland, Oakland, California.
Dongli SongDepartment of Neonatology, Santa Clara Valley Medical Center, San Jose, California.
Anthony J BarkovichDepartment of Neurology, UCSF Benioff Children's Hospital, San Francisco, California.
Roberta A BallardDepartment of Neonatology, UCSF Benioff Children's Hospital, San Francisco, California.
Yvonne W WuDepartment of Neonatology, UCSF Benioff Children's Hospital, San Francisco, California; Department of Neurology, UCSF Benioff Children's Hospital, San Francisco, California. Electronic address: wuy@neuropeds.ucsf.edu.

Funding

UCSF CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR024131 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$111.2M
White matter injury as predictor of outcome in neonatal brain injuryP50NS035902 · NINDS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI FERRIERO, DONNA M. · 1997 to 2012
$14.0M
MRI Mechanisms of Adverse Outcome in Preterm Infants with SeizuresK23NS066137 · NINDS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GLASS, HANNAH CRANLEY · 2010 to 2014
$858k
Inflammation and Cerebral Palsy in Term InfantsK02NS046688 · NINDS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI WU, YVONNE W · 2005 to 2009
$784k
NCRR NIH HHS UL1 RR024131NINDS NIH HHS K02 NS046688NINDS NIH HHS K23 NS066137NINDS NIH HHS P50 NS035902
6 · The paper itself

Abstract

backgroundErythropoietin is neuroprotective in animal models of neonatal hypoxic-ischemic encephalopathy. We previously reported a phase I safety and pharmacokinetic study of erythropoietin in neonates. This article presents the neurodevelopmental follow-up of infants who were enrolled in the phase I clinical trial.

methodsWe enrolled 24 newborns with hypoxic-ischemic encephalopathy in a dose-escalation study. Patients received up to six doses of erythropoietin in addition to hypothermia. All infants underwent neonatal brain magnetic resonance imaging (MRI) reviewed by a single neuroradiologist. Moderate-to-severe neurodevelopmental disability was defined as cerebral palsy with Gross Motor Function Classification System levels III-V or cognitive impairment based on Bayley Scales of Infant Development II mental developmental index or Bayley III cognitive composite score.

resultsOutcomes were available for 22 of 24 infants, at mean age 22 months (range, 8-34 months). There were no deaths. Eight (36%) had moderate-to-severe brain injury on neonatal MRI. Moderate-to-severe disability occurred in one child (4.5%), in the setting of moderate-to-severe basal ganglia and/or thalamic injury. Seven infants with moderate-to-severe watershed injury exhibited the following outcomes: normal (three), mild language delay (two), mild hemiplegic cerebral palsy (one), and epilepsy (one). All 11 patients with a normal brain MRI had a normal outcome.

conclusionsThis study is the first to describe neurodevelopmental outcomes in infants who received high doses of erythropoietin and hypothermia during the neonatal period. The findings suggest that future studies are warranted to assess the efficacy of this new potential neuroprotective therapy.

Indexed as

BrainChild, PreschoolCognition DisordersDose-Response Relationship, DrugErythropoietinFemaleFollow-Up StudiesHumansHypothermia, InducedHypoxia-Ischemia, BrainInfantMagnetic Resonance ImagingMaleNeuropsychological TestsTreatment OutcomeErythropoietinerythropoietinhypoxic-ischemic encephalopathyneonatal encephalopathyneurodevelopmental outcomesneuroprotection

Identifiers

PMID25439577
PMCPMC4402201

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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.