title: Safety of Early High-Dose Recombinant Erythropoietin for Neuroprotection in Very Preterm Infants.
abstract: OBJECTIVE
  To investigate the safety and short term outcome of high dose recombinant human erythropoietin (rhEpo) given shortly after birth and subsequently over the first 2 days for neuroprotection to very preterm infants.
  
  
  METHODS
  Randomized, double masked phase II trial. Preterm infants (gestational age 26 0/7-31 6/7 weeks) were given rhEpo (nt = 229; 3000 U/kg body weight) or NaCl 0.9% (nc = 214) intravenously at 3, 12-18, and 36-42 hours after birth.
  
  
  RESULTS
  There were no relevant differences between the groups for short-term outcomes such as mortality, retinopathy of prematurity, intraventricular hemorrhage, sepsis, necrotizing enterocolitis, and bronchopulmonary dysplasia. At day 7-10, we found significantly higher hematocrit values, reticulocyte, and white blood cell counts, and a lower platelet count in the rhEpo group.
  
  
  CONCLUSIONS
  Early high-dose rhEpo administration to very premature infants is safe and causes no excess in mortality or major adverse events.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00413946.
authors: Division of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. Electronic address: jean-claude.fauchere@usz.ch.
authors: Jean-Claude
authors: JC
authors: Fauchère
authors: Division of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
authors: Brigitte M
authors: BM
authors: Koller
authors: Division of Biostatistics, Institute of Social and Preventive Medicine, University of Zurich, Zurich, Switzerland.
authors: Alois
authors: A
authors: Tschopp
authors: Department of Neonatology, Charité-Universitätsmedizin, Berlin, Germany.
authors: Christof
authors: C
authors: Dame
authors: Division of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
authors: Christoph
authors: C
authors: Ruegger
authors: Division of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
authors: Hans Ulrich
authors: HU
authors: Bucher
mesh_terms: D001997:Bronchopulmonary Dysplasia / Q000453:epidemiology; D002658:Developmental Disabilities / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D020345:Enterocolitis, Necrotizing / Q000453:epidemiology; D004921:Erythropoietin / Q000008:administration & dosage*; D005060:Europe / Q000453:epidemiology; D006400:Hematocrit; D006801:Humans; D020925:Hypoxia-Ischemia, Brain / Q000453:epidemiology; D007231:Infant, Newborn; D007234:Infant, Premature; D020300:Intracranial Hemorrhages / Q000453:epidemiology; D007958:Leukocyte Count; D007969:Leukomalacia, Periventricular / Q000453:epidemiology; D018696:Neuroprotective Agents / Q000008:administration & dosage*; D010976:Platelet Count; D011994:Recombinant Proteins / Q000008:administration & dosage; D017701:Reticulocyte Count; D012178:Retinopathy of Prematurity / Q000453:epidemiology; D018805:Sepsis / Q000453:epidemiology
chemical_list: D018696:Neuroprotective Agents; D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin