Abstract | BACKGROUND: OBJECTIVES: The 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. METHODS: This 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 CONCLUSIONS: Epo 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.
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Authors | Sandra E Juul, Bryan A Comstock, Patrick J Heagerty, Dennis E Mayock, Amy M Goodman, Stephanie Hauge, Fernando Gonzalez, Yvonne W Wu |
Journal | Neonatology
(Neonatology)
Vol. 113
Issue 4
Pg. 331-338
( 2018)
ISSN: 1661-7819 [Electronic] Switzerland |
PMID | 29514165
(Publication Type: Clinical Trial Protocol, Journal Article, Research Support, N.I.H., Extramural)
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Copyright | © 2018 S. Karger AG, Basel. |
Chemical References |
- Neuroprotective Agents
- Erythropoietin
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Topics |
- Asphyxia
(therapy)
- Clinical Trials, Phase III as Topic
- Double-Blind Method
- Erythropoietin
(administration & dosage)
- Female
- Humans
- Hypothermia, Induced
(methods)
- Hypoxia-Ischemia, Brain
(therapy)
- Infant, Newborn
- Logistic Models
- Male
- Multicenter Studies as Topic
- Neuroprotection
- Neuroprotective Agents
(administration & dosage)
- Randomized Controlled Trials as Topic
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