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
Ms. Cairo et al., 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, J PEDIAT, 134(1), 1999, pp. 64-70
Objective: We carried out a randomized placebo-controlled trial in very low
birth weight neonates (VLBWNs), comparing the incidence of nosocomial infe
ctions after the prophylactic use of recombinant human granulocyte-macropha
ge colony-stimulating factor (rhu GM-CSF) versus placebo in VLBWNs.
Study design: VLBWNs (n = 264), weighing 501 to 1000 g, less than or equal
to 72 hours of age were randomly assigned to receive rhu GM-CSF (8 mu g/kg/
d), administered intravenously (n = 134) over 2 hours daily x 7 days and ev
ery other day for 21 days, or placebo (n = 130). The safety, incidence of n
osocomial infections, days of absolute neutrophil count greater than or equ
al to 4000/mm,(3) peripheral blood progenitor studies, and 24-hour polymorp
honuclear leukocyte C3bi receptor expression were compared between the 2 tr
eatment 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, respect
ively). However, there was no difference in the incidence of confirmed noso
comial infections between the 2 treatment groups in this trial (40% vs 39%,
rhu GM-CSF vs placebo; P = NS).
Conclusion: In a large randomized placebo-controlled trial, prophylactic ad
ministration of rhu GM-CSF in VLBWNs does not appear to decrease the incide
nce of nosocomial infections.