Evidence map›Paper›PMID 28099423›Full record

Trial reportPediatric research2017

High-dose erythropoietin population pharmacokinetics in neonates with hypoxic-ischemic encephalopathy receiving hypothermia.

Adam Frymoyer, Sandra E Juul, An N Massaro, Theo K Bammler, Yvonne W Wu

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatric research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03163589 (Effect of Erythropoietin and Hypothermia on Management of Neonatal Hypoxic Ischemic Encephalopathy), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
6.9field-weighted citation impact, top 4% 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.

NCT03163589 phase3unknown statusnot on this map

Effect of Erythropoietin and Hypothermia on Management of Neonatal Hypoxic Ischemic Encephalopathy

TypeinterventionalSponsorAssiut UniversityRan2017 to 2020Enrolled40ConditionsHypoxic-Ischemic EncephalopathyArmsErythropoietin, normal saline
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 29 citations in OpenAlex.

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  3. Target-mediated disposition population pharmacokinetics model of erythropoietin in premature neonates following multiple intravenous and subcutaneous dosing regimens.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2019
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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

5 authors at 4 institutions in 1 country.

Adam FrymoyerDepartment of Pediatrics, Stanford University, Stanford, California.
Sandra E JuulDepartment of Pediatrics, University of Washington, Seattle, Washington.
An N MassaroDepartment of Neonatology, Children's National Health Systems, Washington, DC.
Theo K BammlerDepartment of Environmental and Occupational Health Sciences, University of Washington, Seattle, Washington.
Yvonne W WuDepartment of Neurology, University of California, San Francisco, California.
University of Washington · USChildren's National · USStanford University · USUniversity of California, San Francisco · US

Funding

Intellectual and Developmental Disabilities Research CenterU54HD083091 · NICHD · UNIVERSITY OF WASHINGTON · PI DOHERTY, DANIEL · 2014 to 2019
$7.9M
Pharmacology of Aminophylline for Acute Kidney Injury in Neonates and ChildrenK23HD079557 · NICHD · STANFORD UNIVERSITY · PI FRYMOYER, ADAM · 2014 to 2018
$732k
NICHD NIH HHS K23 HD079557NICHD NIH HHS U54 HD083091
6 · The paper itself

Abstract

backgroundHigh-dose erythropoietin (Epo) is a promising neuroprotective treatment in neonates with hypoxic-ischemic encephalopathy (HIE) receiving hypothermia. We evaluated the pharmacokinetics and dose-exposure relationships of high-dose Epo in this population to inform future dosing strategies.

methodsWe performed a population pharmacokinetic analysis of 47 neonates with HIE treated with hypothermia who received up to six doses of Epo in two previous clinical trials. We compared the ability of different dosing regimens to achieve the target neuroprotective Epo exposure levels determined from animal models of hypoxic-ischemia (i.e., area under the curve during the first 48 h of treatment (AUC

resultsBirth weight scaled via allometry was a significant predictor of Epo clearance and volume of distribution (P < 0.001). After accounting for birth weight, variation in Epo pharmacokinetics between neonates was low (CV% 20%). All 23 neonates who received 1,000 U/kg every 24 h for the first 2 d of therapy achieved the target AUC

conclusionIn neonates with HIE receiving hypothermia, Epo 1,000 U/kg every 24 h for the first 2 d of therapy resulted in consistent achievement of target exposures associated with neuroprotection in animal models.

Indexed as

Hypothermia, InducedArea Under CurveDose-Response Relationship, DrugErythropoietinHumansHypoxia-Ischemia, BrainInfant, NewbornErythropoietin

Identifiers

PMID28099423
PMCPMC5476365
OpenAlexW2575997999

What OpenQuestion holds

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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.