Document Detail

An approach to using recombinant erythropoietin for neuroprotection in very preterm infants.
MedLine Citation:
PMID:  18676556     Owner:  NLM     Status:  MEDLINE    
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.
Jean-Claude Fauchère; Christof Dame; Reinhard Vonthein; Brigitte Koller; Sandra Arri; Martin Wolf; Hans Ulrich Bucher
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Pediatrics     Volume:  122     ISSN:  1098-4275     ISO Abbreviation:  Pediatrics     Publication Date:  2008 Aug 
Date Detail:
Created Date:  2008-08-04     Completed Date:  2008-08-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0376422     Medline TA:  Pediatrics     Country:  United States    
Other Details:
Languages:  eng     Pagination:  375-82     Citation Subset:  AIM; IM    
Clinic of Neonatology, University Hospital Zurich, Zurich, Switzerland.
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MeSH Terms
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*
Follow-Up Studies
Gestational Age
Infant, Newborn
Infant, Premature, Diseases / diagnosis,  drug therapy*,  mortality
Infant, Very Low Birth Weight*
Intensive Care Units, Neonatal
Maximum Tolerated Dose
Reference Values
Retinopathy of Prematurity / drug therapy,  prevention & control
Risk Assessment
Survival Analysis
Treatment Outcome
Reg. No./Substance:
0/Erythropoietin, Recombinant

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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