title: A randomized, double-masked, placebo-controlled trial of recombinant granulocyte colony-stimulating factor administration to preterm infants with the clinical diagnosis of early-onset sepsis.
abstract: OBJECTIVE
  We performed a randomized, double-masked, parallel-groups, placebo-controlled trial of recombinant granulocyte colony-stimulating factor (rG-CSF) administration to 44 preterm neonates who had blood cultures obtained and antibiotics begun because of the clinical diagnosis of early-onset sepsis. Two primary outcome variables were tested 1) mortality and 2) development of nosocomial infections over the 2-week period after dosing.
  
  
  METHODS
  The treatment group (n = 22) received 10 microgram/kg/day of intravenous rG-CSF once daily for 3 days and the placebo group (n = 22) received the same volume of a visually indistinguishable vehicle. Mortality and culture-proven nosocomial infections were recorded. Immediately before the first, second, and third doses, and again 10 days after the first dose, serum concentrations were determined for tumor necrosis factor-alpha, interleukin 6, granulocyte-macrophage colony stimulating factor, and G-CSF, and blood leukocyte counts, absolute neutrophil counts, immature/total neutrophil ratios, platelet counts, and hemoglobin concentrations were measured.
  
  
  RESULTS
  The treatment and placebo groups were of similar gestational age (29 +/- 3 vs 31 +/- 3 weeks) and birth weight (1376 +/- 491 vs 1404 +/- 508 g), and had similar Apgar scores and 24-hour Score for Neonatal Acute Physiology scores. The mortality rate was not different between treatment and placebo groups. However, the occurrence of a subsequent nosocomial infection was lower in the rG-CSF recipients (relative risk:.19; 95% confidence interval:.05-.78). rG-CSF treatment did not alter the serum concentrations of the cytokines measured (except for G-CSF). Serum G-CSF levels and blood neutrophil counts were higher in the treatment than in the placebo group 24 hours and 48 hours after dosing.
  
  
  CONCLUSIONS
  Administration of 3 daily doses of rG-CSF (10 microgram/kg/day) to premature neonates with the clinical diagnosis of early-onset sepsis did not improve mortality but was associated with acquiring fewer nosocomial infections over the subsequent 2 weeks.
authors.affiliation: Department of Pediatrics, Division of Neonatology, Hospital de Clínicas de Porto Alegre, Faculty of Medicine, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.
authors.forename: E
authors.initials: E
authors.lastname: Miura
authors.forename: R S
authors.initials: RS
authors.lastname: Procianoy
authors.forename: C
authors.initials: C
authors.lastname: Bittar
authors.forename: C S
authors.initials: CS
authors.lastname: Miura
authors.forename: M S
authors.initials: MS
authors.lastname: Miura
authors.forename: C
authors.initials: C
authors.lastname: Mello
authors.forename: R D
authors.initials: RD
authors.lastname: Christensen
mesh_terms: D001424:Bacterial Infections / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D001772:Blood Cell Count; D003428:Cross Infection / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D004311:Double-Blind Method; D016179:Granulocyte Colony-Stimulating Factor / Q000097:blood / Q000627:therapeutic use*; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000097:blood; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000188:drug therapy*; D015850:Interleukin-6 / Q000097:blood; D010976:Platelet Count; D011994:Recombinant Proteins; D015996:Survival Rate; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000032:analysis
chemical_list: D006454:Hemoglobins; D015850:Interleukin-6; D011994:Recombinant Proteins; D014409:Tumor Necrosis Factor-alpha; D016179:Granulocyte Colony-Stimulating Factor; D016178:Granulocyte-Macrophage Colony-Stimulating Factor