A multicenter, randomized, placebo-controlled trial of prophylactic recombinant granulocyte-colony stimulating factor in preterm neonates with neutropenia.

Abstract

OBJECTIVE:

To test the hypothesis that prophylactic treatment of neutropenic premature neonates with recombinant granulocyte-colony stimulating factor (rG-CSF) would reduce the incidence of nosocomial infections (NIs).

STUDY DESIGN:

A total of 25 neonatal intensive care units participated in this multicenter, randomized, double-blind, placebo-controlled trial. Premature infants of gestational age (GA) <or= 32 weeks were included if they had a peripheral blood count showing < 1500 neutrophils/mm(3) for at least 24 hours during the first 3 weeks of life. A total of 200 infants received either rG-CSF (10 microg/kg/day) or placebo for 3 days. Primary outcome was survival free of infection for 4 weeks after treatment, assessed in an intention-to-treat analysis.

RESULTS:

A total of 102 infants received rG-CSF (mean GA, 29.2 weeks), and 98 received placebo (mean GA, 29.1 weeks). Survival free of confirmed infection for 4 weeks after treatment was 74/102 in the rG-CSF group and 66/98 in the placebo group (P = .42). However, during 2 weeks, there was a significant difference between groups (86/102 vs 70/98; P = .028).

CONCLUSIONS:

In this population, prophylactic rG-CSF did not significantly increase survival free of infection at 4 weeks after treatment. The transient effect observed at 2 weeks in the most immature infants should be evaluated further.

• Authors: Pierre Kuhn, Jean Messer, Alain Paupe, Sandrine Espagne, Nadine Kacet, Genevieve Mouchnino, Serge Klosowski, Gérard Krim, Sandra Lescure, Stephane Le Bouedec, Pierre Meyer, Dominique Astruc
• Journal: The Journal of pediatrics (J Pediatr) Vol. 155 Issue 3 Pg. 324-30.e1 (Sep 2009) ISSN: 1097-6833 [Electronic] United States
• PMID: 19467544 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor

Topics

• Cross Infection (prevention & control)
• Double-Blind Method
• Female
• Gestational Age
• Granulocyte Colony-Stimulating Factor (therapeutic use)
• Humans
• Infant, Newborn
• Infant, Premature
• Infant, Premature, Diseases (diagnosis, drug therapy)
• Infant, Very Low Birth Weight
• Leukocyte Count
• Male
• Neutropenia (diagnosis, drug therapy)
• Recombinant Proteins
• Treatment Outcome