title: Weekly intravenous administration of recombinant human erythropoietin in infants with the anaemia of prematurity.
abstract: 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.
authors.affiliation: Department of Paediatrics, University Hospital, Lausanne, Switzerland.
authors.forename: D
authors.initials: D
authors.lastname: Beck
authors.forename: E
authors.initials: E
authors.lastname: Masserey
authors.forename: M
authors.initials: M
authors.lastname: Meyer
authors.forename: A
authors.initials: A
authors.lastname: Calame
mesh_terms: D000751:Anemia, Neonatal / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000097:blood / Q000188:drug therapy*; D007275:Injections, Intravenous; D007501:Iron / Q000097:blood; D009503:Neutropenia / Q000139:chemically induced; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D011994:Recombinant Proteins; D004921:Erythropoietin; D007501:Iron