clinical and biochemical effects of recombinant human granulocyte colony-stimulating factor on the prognosis of preterm infants with early onset neonatal sepsis

Background:a doubleblind, placebocontrolled randomized trial was designed to investigate the effects of recombinant human granulocyte colonystimulating factor (rhgcsf) on the prognosis of preterm infants with early onset neonatal sepsis (eons). methods:fifty preterm infants were selected from the neonatal intensive care unit (nicu) of qaem hospital, mashhad, iran in 2011. they were randomized to rhgcsf (intervention group, n = 25) or identical placebo (control group, n = 25) for 3 days. the following blood parameters were measured: white blood cells count (wbc), absolute neutrophil count (anc), serum level of highsensitivity creactive protein (hscrp), and the ratio of immature to total neutrophils. in addition, the mortality rate, adverse effects, and duration of hospital stay were evaluated as clinical parameters. results:at baseline, both groups were not significantly different (p > 0.05) except for the hscrp level (p = 0.024) and hypoglycemia (p = 0.001). compared with the controls, significant improvements were only observed in wbc (p = 0.001) and anc (p = 0.010) of the intervention group. the mean difference in the wbc, anc, hscrp level, and the ratio of immature to total neutrophils between the baseline and 3day posttreatment values was higher in the controls than the intervention group. more than 90% of the patients exposed to either rhgcsf or placebo hospitalized for over 72 hours and no significant difference was found between them (p = 0.946). in each group, a decease was recorded (4.0%) during the hospitalization. conclusions:the rhgcsf administration could effectively improve wbc and anc. no significant changes were observed in mortality rate, adverse effects, and hospital stay after the treatment.