Granulocyte Colony-stimulating Factor for Preterms with Sepsis and Neutropenia: A Randomized Controlled Trial

Abstract

Background: Bacterial sepsis is one of the major causes of mortality in newborn infants. Mortality increases when sepsis is associated with neutropenia.

Materials and methods: We conducted a prospective, randomized, double-blind, placebo-controlled trial of recombinant human granulocyte colony-stimulating factor on preterm neonates (gestational age (GA) <34 weeks) with sepsis and absolute neutrophil count (ANC) of <1500 cells/mm(3). Mortality, duration of Neonatal Intensive Care Unit (NICU) stay, hematological parameters (ANC, platelet count, and total leukocyte count) were compared between the two groups. The GCSF group (n=39) received GCSF intravenously in a single daily dose of 10 μg/kg/day in a 5% dextrose solution over 20-40 min for three consecutive days, while the control group (n=39) received placebo of an equivalent volume of 5% dextrose.

Results: Baseline demographic profile among the two groups was comparable. Mortality rate in the GCSF group was significantly lower than in the control group (10% vs. 35%; P<0.05). By day 3 of treatment, ANC in the GCSF group was significantly higher (3521±327) compared to 2094±460 in the control group, with P value being <0.05. Duration of NICU stay also decreased significantly in the GCSF group.

Conclusion: The administration of GCSF in preterms with septicemia and neutropenia resulted in lower mortality rates. Further studies are required to confirm our results and establish this adjunctive therapy in neonatal sepsis.

Keywords: Granulocyte colony-stimulating factor; neonates; neutropenia; preterm; septicemia.

Figure 1

Flow of patients through the trial