Safety of Early High-Dose Recombinant Erythropoietin for Neuroprotection in Very Preterm Infants

J Pediatr. 2015 Jul;167(1):52-7.e1-3. doi: 10.1016/j.jpeds.2015.02.052. Epub 2015 Apr 8.

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.

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.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bronchopulmonary Dysplasia / epidemiology
  • Developmental Disabilities / prevention & control*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Enterocolitis, Necrotizing / epidemiology
  • Erythropoietin / administration & dosage*
  • Europe / epidemiology
  • Hematocrit
  • Humans
  • Hypoxia-Ischemia, Brain / epidemiology
  • Infant, Newborn
  • Infant, Premature*
  • Intracranial Hemorrhages / epidemiology
  • Leukocyte Count
  • Leukomalacia, Periventricular / epidemiology
  • Neuroprotective Agents / administration & dosage*
  • Platelet Count
  • Recombinant Proteins / administration & dosage
  • Reticulocyte Count
  • Retinopathy of Prematurity / epidemiology
  • Sepsis / epidemiology

Substances

  • Neuroprotective Agents
  • Recombinant Proteins
  • epoetin beta
  • Erythropoietin

Associated data

  • ClinicalTrials.gov/NCT00413946