Recombinant Human Granulocyte Colony-stimulating Factor in Preterm Neonates with Sepsis and Relative Neutropenia: a Randomized, Single-Blind, Non-placebo-controlled Trial

We performed a prospective, randomized, single-blind, non-placebo-controlled trial on preterm (< 37 weeks) neonates (birth weight < 2000g) with sepsis and absolute neutrophil counts (ANC) < 5000 cells mm(-3) to study the effect of recombinant human granulocyte colony-stimulating factor (rhG-CSF) on all-cause-neonatal mortality and hematological parameters (total leucocyte (TLC, ANC, absolute monocyte and absolute platelet counts). The rhG-CSF group (n = 20) received 10 mu g/kg/day of intravenous infusion of rhG-CSF once daily for 5 days along with conventional therapy, and the control group (n = 20) received conventional therapy alone. Hematological parameters on Days 0, 1, 3, 5, 7 and 14 of study entry and all-cause mortality rates at discharge were recorded. Baseline characteristics between the rhG-CSF and control group including mean birth weight (1395 +/- 289 vs. 1500 +/- 231g), mean gestational age (31.5 +/- 2.68 vs. 32.6 +/- 2.23 weeks), initial neonatal complaints and maternal characteristics were comparable. Mortality rates were significantly less among the rhG-CSF group (3/20 (15%) vs. 7/20 (35%), p < 0.05). By Day 5 (for TLC) and Day 3 (for ANC) of start of the intervention, rhG-CSF group had significantly higher TLC (8189 +/- 1570 vs. 6936 +/- 1128 cells mm(-3), p < 0.05) and ANC (4756 +/- 1089 vs. 4213 +/- 354 cells mm(-3), p < 0.05) compared to controls. ANC levels recovered to levels > 5000 cells mm(-3) faster in the rhG-CSF group, with 80% babies having ANC > 5000 cells mm(-3) by Day 7 of study entry compared with 35% in the control group (p < 0.05). Preterm neonates with sepsis and neutropenia treated with rhG-CSF adjunctive therapy have decreased all-cause mortality at discharge and a quicker recovery of their total leucocyte and ANC.