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There is Insufficient Evidence to Support the Use of G-CSF in Neonates with Sepsis


  • In neonates with sepsis, does the use of recombinant G-CSF decrease mortality?

Clinical Bottom Lines

  1. At this time, there is insufficient evidence to support the use of G-CSF as adjuvant therapy in neonates with sepsis.
  2. Further studies are needed to elucidate the possible role of G-CSF in low birth weight neonates with sepsis and in neonates with sepsis and neutropenia.

Summary of Key Evidence

  1. In a meta-analysis of five studies, including 73 G-CSF recipients and 82 control subjects, an aggregate calculation found that infants receiving G-CSF had decreased mortality (OR 0.17).1
  2. However, only 3 of the studies were double-blinded, randomized, placebo controlled trials. The other 2 studies used a historical control. There was no significant reduction in mortality when considering only the placebo-controlled trials (OR 0.43).
  3. Among the subset of patients with birthweight less than 2000 grams and patients with neutropenia, there were decreases in mortality among recipients of G-CSF.

Additional Comments

  • More research is needed focusing on lower birth weight neonates and those with neutropenia.
  • The population varied among studies in terms of definition of sepsis, definition of neutropenia, and gestational age.
  • No clinically significant side effects were noted in the studies mentioned.


  1. Bernstein HM, Pollock B, Calhoun D, Christensoen R. Administration of recombinant granulocyte colony-stimulating factor to neonates with septicemia: A meta-analysis. Journal of Pediatrics 2001;138: 917-920.

CAT Author: Lauren Gold, MD

CAT Appraisers: Robert Schumacher, MD

Date appraised: March 3, 2003

Last updated June 13, 2003
Department of Pediatrics and Communicable Diseases
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