Granulocyte-Colony Stimulating Factor in Neonates with Neutropenia and Sepsis
Granulocyte-Colony Stimulating Factor in Neonates with Neutropenia and Sepsis
ABSTRACT & COMMENTARY
Synopsis: Thirteen of 14 neonates with presumed sepsis and neutropenia were given recombinant human granulocyte-colony stimulation factor 5 mcg/kg/d IV for five days, consistently producing an increase in absolute neutrophil count.
Source: Barak E, et al. The in vivo effect of recombinant human granulocyte-colony stimulating factor in neutropenic neonates with sepsis. Eur J Pediatr 1997;156:643-646.
Sepsis remains a major cause of morbidity and mortality in the newborn period, and these complications are markedly increased when the septic newborn is also neutropenic. Barak and associates from Rehovat, Israel, gave recombinant human granulocyte-colony stimulating factor (rhG-CSF) to 14 premature infants (gestational age, 26-35 weeks) with neutropenia and presumed or confirmed early sepsis. Presumed sepsis was based on the presence of at least three of the following clinical signs: fever, poor performance, increased requirements for ventilation or oxygenation, abdominal distension, and persistent metabolic acidosis. Neutropenia was defined as an absolute neutrophil count (ANC) less than 2 ´ 109d mL. The mean ANC was statistically higher than control after five days. There were two early deaths (14%) in the treatment, compared to nine deaths (38%) in the historical control group. Treatment was well tolerated, and there was no clinical or hematological toxicity.
COMMENT BY HOWARD A. PEARSON, MD
As Barak et al note, "despite advances in neonatal intensive care and more effective antibiotics, sepsis remains as a major cause of morbidity and mortality in the neonatal period." When sepsis occurs in a neutropenic neonate, the mortality rate is 80-90%. Other studies in septic newbornsmost of whom were not neutropenichave shown that rhG-CSF treatment increased ANC. This pilot study investigated the effects of rhG-CSF given intravenously once a day for five days (ANC < 2 ´ 109/L) in neutropenic newborns.
In three infants, the dose was increased because of an inadequate response. In one infant, the dose was decreased because of an "excessive ANC" response. The treatment group was compared to 24 matched historical controls.
Administration of rhG-CSF produced an increase in ANC more than 5 ´ 109/L. At the end of treatment, the ANC was significantly higher than the historical control groups. There were two deaths in the treated group (14%), compared to nine deaths (38%) in the historical group.
It should be noted that sepsis was bacteriologically proven in only four of nine treatment infants and 13 of 24 controls. The response was fairly prompt in that the ANC of the treatment group exceeded 3 ´ 109/L by 48 hours after institution of therapy.
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