Abstract 27

Background Incidence of neonatal sepsis increases with decreasing gestational age and is most frequently associated with neutropenia in babies <1500g. Haemopoietic growth factors may be of benefit, but safety in sick, neutropenic, septic neonates has not previously been evaluated.

Aims To assess safety of rhG-CSF in septic preterm babies, with relative or absolute neutropenia. Secondary objectives were to evaluate mortality and preliminary markers of efficacy.

Methods 28 Neonates requiring intensive care, of >25 weeks gestation, with birth weights 500-1500g were recruited if the ANC (absolute neutrophil count) was <5×109/l, when they received antibiotics for documented or suspected sepsis. Randomised babies received either placebo or 10 mcg/kg/day rhG-CSF iv, for a maximum of 14 days. ANC and a number of potential treatment-related adverse events were evaluated, including thrombocytopenia.

Results Infection was confirmed in 8/15 control and 6/13 rhG-CSF-treated babies, and probable in 6/15 and 5/13 respectively. Median (range) days to ANC recovery was 2 (1-5) in the rhG-CSF group compared to 5 (1-30) in controls (p<0.001). One death occurred in the rhG-CSF group compared to 4 in controls (NS). Thrombocytopenia occurred in 7/15 controls and 2/13 of the treatment group (p<0.05). Overall treatment-related adverse side-effects occurred in 6/15 controls versus 2/13 of rhG-CSF-treated babies (NS).

Conclusions Used as an intervention during confirmed or probable sepsis, rhG-CSF increased ANC recovery with no acute adverse events, but efficacy remains unproven.