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 µg/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.