PEDIATRICS Vol. 107 No. 1 January 2001, pp. 30-35

A Randomized, Double-Masked, Placebo-Controlled Trial of Recombinant Granulocyte Colony-Stimulating Factor Administration to Preterm Infants With the Clinical Diagnosis of Early-Onset Sepsis

Received Nov 24, 1999; accepted Apr 17, 2000.

Ernani Miura^*, Renato S. Procianoy^*, Cristina Bittar^*, Clarissa S. Miura^*, Maurício S. Miura^*, Cíntia Mello^*, and Robert D. Christensen

From the ^* Department of Pediatrics, Division of Neonatology, Hospital de Clínicas de Porto Alegre, Faculty of Medicine, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil; and the  Department of Pediatrics, Division of Neonatology, University of Florida College of Medicine, Gainesville, Florida.

Objective.  We performed a randomized, double-masked, parallel-groups, placebo-controlled trial of recombinant granulocyte colony-stimulating factor (rG-CSF) administration to 44 preterm neonates who had blood cultures obtained and antibiotics begun because of the clinical diagnosis of early-onset sepsis. Two primary outcome variables were tested 1) mortality and 2) development of nosocomial infections over the 2-week period after dosing.

Design and Methods.  The treatment group (n = 22) received 10 µg/kg/day of intravenous rG-CSF once daily for 3 days and the placebo group (n = 22) received the same volume of a visually indistinguishable vehicle. Mortality and culture-proven nosocomial infections were recorded. Immediately before the first, second, and third doses, and again 10 days after the first dose, serum concentrations were determined for tumor necrosis factor-, interleukin 6, granulocyte-macrophage colony stimulating factor, and G-CSF, and blood leukocyte counts, absolute neutrophil counts, immature/total neutrophil ratios, platelet counts, and hemoglobin concentrations were measured.

Results.  The treatment and placebo groups were of similar gestational age (29 ± 3 vs 31 ± 3 weeks) and birth weight (1376 ± 491 vs 1404 ± 508 g), and had similar Apgar scores and 24-hour Score for Neonatal Acute Physiology scores. The mortality rate was not different between treatment and placebo groups. However, the occurrence of a subsequent nosocomial infection was lower in the rG-CSF recipients (relative risk: .19; 95% confidence interval: .05-.78). rG-CSF treatment did not alter the serum concentrations of the cytokines measured (except for G-CSF). Serum G-CSF levels and blood neutrophil counts were higher in the treatment than in the placebo group 24 hours and 48 hours after dosing.

Conclusions.  Administration of 3 daily doses of rG-CSF (10 µg/kg/day) to premature neonates with the clinical diagnosis of early-onset sepsis did not improve mortality but was associated with acquiring fewer nosocomial infections over the subsequent 2 weeks.  Key words:  granulocyte colony-stimulating factor, neutropenia, early-onset sepsis, absolute neutrophil count, neutrophil storage pool, neutrophil proliferative pool..

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