Weekly intravenous administration of recombinant human erythropoietin in infants with the anaemia of prematurity

Eur J Pediatr. 1991 Sep;150(11):767-72. doi: 10.1007/BF02026707.


To study the safety and efficacy of administering human recombinant erythropoietin (rHuEPO) to infants with anaemia of prematurity, a combined phase I/II trial of weekly intravenous injections for 4 weeks was undertaken. We treated 16 infants with 10, 25, 50, 100 or 200 units/kg body weight in groups of two to four patients per dose level. They were all born prematurely (mean gestational age: 29 weeks; range 27-32), had a mean post-natal age of 42 days (range: 25-59) and haemoglobin concentration of 87 g/l (range: 72-94) when treatment was started. Four patients (25%) needed a transfusion during the trial, one at day 7 treated with 10 units/kg and 3 at days 15, 25, 29 with 100 units/kg. In the others, a progressive rise in mean haemoglobin values was seen in each group after 21 days of treatment, without a dose-dependent effect. A positive change in absolute reticulocyte counts with a peak after 7-14 days of therapy was observed with low (25-50 units/kg) but not with higher doses, with a significant difference at day 14 between 25 and 100 units/kg (P less than 0.01). A dose-limiting severe neutropenia (absolute neutrophil count less than 0.5 x 10(9)/l) occurred transiently in five patients, with doses greater than 25 units/kg. No infectious complication and no sign of iron deficiency were observed. Weekly low doses of rHuEPO appear safe, convenient to administer and able to induce a reticulocytic response in infants with anaemia of prematurity. A phase III placebo-controlled trial is needed to confirm these results. Neutropenia associated with rHuEPO administration in infants might be related to their stage of human ontogeny.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial

MeSH terms

  • Anemia, Neonatal / blood
  • Anemia, Neonatal / drug therapy*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Evaluation
  • Erythropoietin / administration & dosage*
  • Erythropoietin / adverse effects
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Premature, Diseases / blood
  • Infant, Premature, Diseases / drug therapy*
  • Injections, Intravenous
  • Iron / blood
  • Neutropenia / chemically induced
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects


  • Recombinant Proteins
  • Erythropoietin
  • Iron