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PEDIATRICS Vol. 102 No. 1 July 1998, pp. 6-13

A Randomized, Placebo-Controlled Trial of Granulocyte Colony-stimulating Factor Administration to Newborn Infants With Neutropenia and Clinical Signs of Early-onset Sepsis

Received Jul 31, 1997; accepted Jan 19, 1998.

Kurt R. Schibler, Karen A. Osborne, Ling Y. Leung, Trong V. Le, Shawna I. Baker, and Dixie D. Thompson

From the Department of Pediatrics, Division of Neonatology, and the Clinical Research Center, University of Utah School of Medicine, Salt Lake City, Utah.

Objective.  To determine whether recombinant human granulocyte colony-stimulating factor (G-CSF) administration: 1) accelerates production of neutrophils; 2) increases bone marrow stored and precursor neutrophils; and 3) is safe in newborn infants with neutropenia and clinical signs of early-onset sepsis.

Study Design.  We randomized 20 infants with neutropenia and clinical signs of early-onset sepsis in the first 3 days of life to receive G-CSF (10 µg/kg/d) or placebo for 3 days. Entry criteria included neutropenia as defined by Manroe criteria, an elevated immature to total neutrophil ratio [(I/T) >= 0.25], and a requirement for ventilatory support. Cultures were obtained and antibiotics initiated on all study infants. Circulating absolute neutrophil count (ANC), I/T ratio, bone marrow neutrophil storage pool (NSP) and neutrophil proliferative pool (NPP), and plasma G-CSF concentrations were evaluated. Also, severity of illness as determined using the Score for Neonatal Acute Physiology (SNAP), morbidity, and mortality were recorded.

Results.  Circulating ANC increased in both G-CSF and placebo recipients by day 1. Also, the I/T neutrophil ratio decreased in both G-CSF and placebo recipients. There were no significant differences in the ANC or I/T ratio between the two groups during the study period. Similarly, bone marrow NSP and NPP did not differ between G-CSF and placebo recipients at study entry or day 2. No differences were observed in the secondary outcome measures including severity of illness, morbidity, and mortality.

Conclusions.  Administration of recombinant G-CSF to infants with neutropenia and clinical signs of early-onset sepsis did not increase circulating ANC, or bone marrow NSP and NPP compared with placebo. No differences were observed between G-CSF and placebo recipients in severity of illness, morbidity, or mortality. No adverse effects of G-CSF administrations were noted.

Key words: granulocyte colony-stimulating factor, neutropenia, early-onset sepsis, absolute neutrophil count, neutrophil storage pool, neutrophil proliferative pool.




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