University of Michigan
Department of Pediatrics
Evidence-Based Pediatrics Web Site

Question

• 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.

Citation

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