| An approach to using recombinant erythropoietin for neuroprotection in very preterm infants. | |
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MedLine Citation:
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PMID: 18676556 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: Erythropoietin has been shown to be protective against hypoxic-ischemic and inflammatory injuries in cell culture, animal models of brain injury, and clinical trials of adult humans. The rationale for our study was that early administration of high-dose recombinant human erythropoietin may reduce perinatal brain injury (intraventricular hemorrhage and periventricular leukomalacia) in very preterm infants and improve neurodevelopmental outcome. We investigated whether administration of high-dose recombinant human erythropoietin to very preterm infants shortly after birth and subsequently during the first 2 days is safe in terms of short-term outcome. METHODS: This was a randomized, double-masked, single-center trial with a 2:1 allocation in favor of recombinant human erythropoietin. Preterm infants (gestational age: 24 to 31 weeks) were given recombinant human erythropoietin or NaCl 0.9% intravenously 3, 12 to 18, and 36 to 42 hours after birth. RESULTS: The percentage of infants who survived without brain injury or retinopathy was 53% in the recombinant human erythropoietin group and 60% in the placebo group. There were no relevant differences regarding short-term outcomes such as intraventricular hemorrhage, retinopathy, sepsis, necrotizing enterocolitis, and bronchopulmonary dysplasia. For 5 infants who were in the recombinant human erythropoietin group and had a gestational age of <26 weeks, withdrawal of intensive care was decided (3 of 5 with severe bilateral intraventricular hemorrhage, 2 of 5 with pulmonary insufficiency); no infant of the control group died. Recombinant human erythropoietin treatment did not result in significant differences in blood pressure, cerebral oxygenation, hemoglobin, leukocyte, and platelet count. CONCLUSIONS: No significant adverse effects of early high-dose recombinant human erythropoietin treatment in very preterm infants were identified. These results enable us to embark on a large multicenter trial with the aim of determining whether early high-dose administration of recombinant human erythropoietin to very preterm infants improves neurodevelopmental outcome at 24 months' and 5 years' corrected age. |
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Authors:
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Jean-Claude Fauchère; Christof Dame; Reinhard Vonthein; Brigitte Koller; Sandra Arri; Martin Wolf; Hans Ulrich Bucher |
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Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Pediatrics Volume: 122 ISSN: 1098-4275 ISO Abbreviation: Pediatrics Publication Date: 2008 Aug |
Date Detail:
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Created Date: 2008-08-04 Completed Date: 2008-08-22 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0376422 Medline TA: Pediatrics Country: United States |
Other Details:
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Languages: eng Pagination: 375-82 Citation Subset: AIM; IM |
Affiliation:
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Clinic of Neonatology, University Hospital Zurich, Zurich, Switzerland. |
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| MeSH Terms | |
Descriptor/Qualifier:
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Apgar Score Brain Diseases / drug therapy, mortality, prevention & control* Cerebral Hemorrhage / drug therapy, mortality, prevention & control Developmental Disabilities / drug therapy, mortality, prevention & control* Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Erythropoietin, Recombinant / administration & dosage* Female Follow-Up Studies Gestational Age Humans Infant, Newborn Infant, Premature, Diseases / diagnosis, drug therapy*, mortality Infant, Very Low Birth Weight* Intensive Care Units, Neonatal Male Maximum Tolerated Dose Probability Reference Values Retinopathy of Prematurity / drug therapy, prevention & control Risk Assessment Survival Analysis Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Erythropoietin, Recombinant |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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