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PEDIATRICS Vol. 107 No. 1 January 2001, pp. 36-41

A Randomized Trial of Granulocyte-Macrophage Colony-Stimulating Factor in Neonates With Sepsis and Neutropenia

Received Aug 17, 1999; accepted Aug 9, 2000.

Kemal B&idot;lg&idot;n, MD, Ahmet Yaramis, Kenan Haspolat, M. Ali Tas, Sacit Günbey, and Orhan Derman

From the Department of Pediatrics, Dicle Medical School, Diyarbakir, Turkey.

Objectives.  To determine whether adjunctive therapy with recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) could reverse sepsis-associated neonatal neutropenia and improve neonatal survival and to assess its safety compared with conventional therapy in a control group.

Study Design.  This prospective, randomized, controlled trial was performed in 60 infants with neutropenia and clinical signs of sepsis. A subcutaneous injection of rhGM-CSF (5 µg/kg/day) was administered to 30 of the patients for 7 consecutive days. Hematologic parameters (absolute neutrophil, eosinophil, monocyte, lymphocyte counts, and platelet number) and outcome were compared with 30 conventionally treated (control) patients.

Results.  Twenty-five patients from the GM-CSF-treated group and 24 from the conventionally treated group had early-onset sepsis (<= 3 days' postnatal age), and the other 11 patients had late-onset sepsis (>3 days' postnatal age). There was no difference between groups in terms of birth weight; gestational age; gender; maturity; maternal age; and incidence of prolonged rupture of membranes, maternal hypertension, or severity of sepsis. All neonates tolerated GM-CSF well with no adverse reactions. The absolute neutrophil count on day 7 was significantly increased in the GM-CSF-treated group compared with the conventionally treated group: 8088 ± 2822/mm3 versus 2757 ± 823/mm3. The mean platelet count was significantly higher on days 14 in the GM-CSF-treated group compared with conventionally treated group: 266 867 ± 55 102/mm3 versus 229 200 ± 52 317/mm3. Hematologic parameters were otherwise similar between groups before treatment and on day 28. Twenty-seven neonates in the rh-GMCSF group and 21 in the control group survived to hospital discharge. The mortality rate in the rhGM-CSF group (10%) was significantly lower than in the conventionally treated group (30%).

Conclusion.  Treatment with rhGM-CSF is associated with an increase in absolute neutrophil, eosinophil, monocyte, lymphocyte, and platelet counts and decreased mortality in critically ill septic neutropenic neonates. These results suggest that rhGM-CSF may be effective in the treatment of neonatal sepsis with neutropenia, and further randomized trials are needed to confirm its beneficial effects.  Key words:  recombinant human granulocyte-macrophage colony-stimulating factor, neonates, neutropenia, sepsis.




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