Document Detail


A multicenter, randomized, placebo-controlled trial of prophylactic recombinant granulocyte-colony stimulating factor in preterm neonates with neutropenia.
MedLine Citation:
PMID:  19467544     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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; G??rard Krim; Sandra Lescure; Stephane Le Bouedec; Pierre Meyer; Dominique Astruc
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-05-24
Journal Detail:
Title:  The Journal of pediatrics     Volume:  155     ISSN:  1097-6833     ISO Abbreviation:  J. Pediatr.     Publication Date:  2009 Sep 
Date Detail:
Created Date:  2009-09-07     Completed Date:  2009-09-30     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0375410     Medline TA:  J Pediatr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  324-30.e1     Citation Subset:  AIM; IM    
Affiliation:
R??animation n??onatale, Service de P??diatrie 2, H??pital de Hautepierre, CHRU Strasbourg, France. pierre.kuhn@chru-strasbourg.fr
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00213759
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MeSH Terms
Descriptor/Qualifier:
Cross Infection / prevention & control
Double-Blind Method
Female
Gestational Age
Granulocyte Colony Stimulating Factor, Recombinant / 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*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Granulocyte Colony Stimulating Factor, Recombinant

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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