Published online August 1, 2008
PEDIATRICS Vol. 122 No. 2 August 2008, pp. 375-382 (doi:10.1542/peds.2007-2591)
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ARTICLE

An Approach to Using Recombinant Erythropoietin for Neuroprotection in Very Preterm Infants

Jean-Claude Fauchère, MDa, Christof Dame, Prof, MDb, Reinhard Vonthein, Drc, Brigitte Koller, RNa, Sandra Arri, MDa, Martin Wolf, PhDa and Hans Ulrich Bucher, Prof, MDa

a Clinic of Neonatology, University Hospital Zurich, Zurich, Switzerland
b Department of Neonatology, Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Berlin, Germany
c Department of Medical Biometry, University of Tübingen, Tübingen, Germany

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.

Key Words: premature infant • erythropoietin • neurodevelopment • outcome • brain injury • very low birth weight infant • intraventricular hemorrhage • retinopathy of prematurity

Abbreviations: Epo—erythropoietin • rhEpo—recombinant human erythropoietin • EpoR—erythropoietin receptor • ROP—retinopathy of prematurity • IVH—intraventricular hemorrhage • PVL—periventricular leukomalacia • GA—gestational age • THI—total hemoglobin index • TOI—tissue oxygenation index • NIRS—near infrared spectroscopy • OR—odds ratio • CI—confidence interval • IQR—interquartile range • CSF—cerebrospinal fluid • BBB—blood-brain barrier

Accepted Dec 28, 2007.


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