title: A randomized, double-blind, placebo-controlled trial of prophylactic recombinant human granulocyte-macrophage colony-stimulating factor to reduce nosocomial infections in very low birth weight neonates.
abstract: OBJECTIVE
  We carried out a randomized placebo-controlled trial in very low birth weight neonates (VLBWNs), comparing the incidence of nosocomial infections after the prophylactic use of recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) versus placebo in VLBWNs.
  
  
  METHODS
  VLBWNs (n = 264), weighing 501 to 1000 g, </=72 hours of age were randomly assigned to receive rhu GM-CSF (8 microg/kg/d), administered intravenously (n = 134) over 2 hours daily x 7 days and every other day for 21 days, or placebo (n = 130). The safety, incidence of nosocomial infections, days of absolute neutrophil count >/=4000/mm,3 peripheral blood progenitor studies, and 24-hour polymorphonuclear leukocyte C3bi receptor expression were compared between the 2 treatment groups.
  
  
  RESULTS
  No (grade III/IV) toxicity or adverse events were associated with rhu GM-CSF. The absolute neutrophil count and absolute eosinophil count were significantly elevated in the rhu GM-CSF group on days 7 (P =.001), 14 (P =.001), and 21 (P =.007) and on days 7 and 28 (P =.012 and P =.001, respectively). However, there was no difference in the incidence of confirmed nosocomial infections between the 2 treatment groups in this trial (40% vs 39%, rhu GM-CSF vs placebo; P = NS).
  
  
  CONCLUSIONS
  In a large randomized placebo-controlled trial, prophylactic administration of rhu GM-CSF in VLBWNs does not appear to decrease the incidence of nosocomial infections.
authors.affiliation: Georgetown University and Lombardi Cancer Center, Washington, DC 20007, USA.
authors.forename: M S
authors.initials: MS
authors.lastname: Cairo
authors.forename: J
authors.initials: J
authors.lastname: Agosti
authors.forename: R
authors.initials: R
authors.lastname: Ellis
authors.forename: J J
authors.initials: JJ
authors.lastname: Laver
authors.forename: B
authors.initials: B
authors.lastname: Puppala
authors.forename: R
authors.initials: R
authors.lastname: deLemos
authors.forename: L
authors.initials: L
authors.lastname: Givner
authors.forename: M
authors.initials: M
authors.lastname: Nesin
authors.forename: J G
authors.initials: JG
authors.lastname: Wheeler
authors.forename: T
authors.initials: T
authors.lastname: Seth
authors.forename: C
authors.initials: C
authors.lastname: van de Ven
authors.forename: A
authors.initials: A
authors.lastname: Fanaroff
mesh_terms: D003428:Cross Infection / Q000517:prevention & control*; D004311:Double-Blind Method; D004804:Eosinophils / Q000187:drug effects; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight; D007275:Injections, Intravenous; D007958:Leukocyte Count / Q000187:drug effects; D008297:Male; D011994:Recombinant Proteins; D014481:United States
chemical_list: D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor