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Safety of Early High-Dose Recombinant Erythropoietin for Neuroprotection in Very Preterm Infants.
Fauchère, Jean-Claude; Koller, Brigitte M; Tschopp, Alois; Dame, Christof; Ruegger, Christoph; Bucher, Hans Ulrich.
Afiliação
  • Fauchère JC; Division of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. Electronic address: jean-claude.fauchere@usz.ch.
  • Koller BM; Division of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
  • Tschopp A; Division of Biostatistics, Institute of Social and Preventive Medicine, University of Zurich, Zurich, Switzerland.
  • Dame C; Department of Neonatology, Charité-Universitätsmedizin, Berlin, Germany.
  • Ruegger C; Division of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
  • Bucher HU; Division of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
J Pediatr ; 167(1): 52-7.e1-3, 2015 Jul.
Article em En | MEDLINE | ID: mdl-25863661
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. STUDY DESIGN: 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. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00413946.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Recém-Nascido Prematuro / Deficiências do Desenvolvimento / Eritropoetina / Fármacos Neuroprotetores Tipo de estudo: Clinical_trials Limite: Humans / Newborn País/Região como assunto: Europa Idioma: En Revista: J Pediatr Ano de publicação: 2015 Tipo de documento: Article País de publicação: Estados Unidos
Texto completo
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Recém-Nascido Prematuro / Deficiências do Desenvolvimento / Eritropoetina / Fármacos Neuroprotetores Tipo de estudo: Clinical_trials Limite: Humans / Newborn País/Região como assunto: Europa Idioma: En Revista: J Pediatr Ano de publicação: 2015 Tipo de documento: Article País de publicação: Estados Unidos