G-CSF and GM-CSF for treating or preventing neonatal infections

Area of Science:

• Neonatal medicine
• Hematology
• Pharmacology

Background:

• Colony stimulating factors (CSFs), including granulocyte-macrophage colony stimulating factor (GM-CSF) and granulocyte colony stimulating factor (G-CSF), are cytokines that enhance neutrophil and monocyte production and function.
• Two strategies are employed: treating established infections in preterm infants, particularly those with low neutrophil counts, and prophylactic use to prevent sepsis.

Purpose of the Study:

• To evaluate the efficacy and safety of G-CSF or GM-CSF in newborn infants for treating systemic infections and for prophylaxis against nosocomial infections.
• To analyze the impact of neutropenia on treatment outcomes in a subgroup analysis.

Main Methods:

• A systematic review of randomized controlled trials (RCTs) was conducted using multiple databases (PubMed, EMBASE, MEDLINE, Cochrane Library) searched up to April 2003.
• Studies included newborn infants in intensive care receiving G-CSF or GM-CSF for treatment of infection or prophylaxis against sepsis.
• Data analysis involved calculating relative risks (RR), risk differences (RD), and number needed to treat (NNT) using a fixed effect model.

Main Results:

• Seven treatment studies (257 infants) found no evidence that CSFs reduce all-cause mortality in preterm infants with suspected systemic infection.
• A subgroup analysis of 97 neutropenic infants showed a significant reduction in mortality by day 14 with CSF treatment (RR 0.34).
• Three prophylaxis studies (359 neonates) did not demonstrate a significant reduction in mortality with GM-CSF; however, one study suggested potential protection in neutropenic infants.

Conclusions:

• Insufficient evidence currently supports the routine use of G-CSF or GM-CSF in neonatal practice for treating or preventing infections.
• No adverse effects of CSF use were reported in the reviewed studies.
• Further adequately powered trials are recommended to investigate the potential mortality-reducing effect of CSF treatment in neutropenic infants with severe infections.