Effect of recombinant human granulocyte colony stimulating factor (rhG-CSF) for the treatment of neonates in presumed sepsis with neutropenia.

Bacterial sepsis continues to be an important cause of morbidity and mortality in neonates. In newborn with presumed sepsis, short-term treatment with rhG-CSF increased the neutrophil count and more importantly improved survival. The objective of the study was to evaluate the effect of rhG-CSF for the treatment of neonates in presumed sepsis with neutropenia. This interventional study was conducted in the Department of Neonatology, BSMMU, Dhaka during July 2009 to May 2010. Total 30 neonates of presumed sepsis with absolute neutrophil count ≤5000/cumm, age<28 days and birth weight 1000-2000g were included in the study. A subcutaneous injection of rhG-CSF (10μgm/kg/day) was administered to 15 neonates for 5 consecutive days (study group) and 15 neonates did not receive it (control group) in addition to standard antibiotic protocol for neonatal sepsis. Baseline characteristics of 30 neonates shows male/female ratio, weight on admission, gestational age were similar in both groups. Among 30 neonates of clinically presumed sepsis 7(23%) were culture proven. E. coli was the most common organism. After 24 hours of treatment mean ANC was increased more in study group (p<0.05) compared to control group. Mean ANC after 72 hours of treatment was increased significantly in study group than control group: 5940.00 versus 5706.00 (p=0.01). At the end of treatment, the mean ANC was higher than that of control (p=0.001). Twelve neonates in study group and ten neonates in control group survived to hospital discharge. The mortality rate in the study group 3/15(20%) and in control group 5/15(33%) were not significant. Duration of hospital stay was less in study group but not significant. The study concluded that before routine use of rhG-CSF in neonatal sepsis with neutropenia further large scale, multi-centre, randomized, placebo controlled trial are needed to validate the beneficial effect.