A Multicenter, Randomized, Placebo-Controlled Trial of Prophylactic Recombinant Granulocyte-Colony Stimulating Factor in Preterm Neonates with Neutropenia - 09/08/11
, Jean Messer, MD a, b, Alain Paupe, MD c, Sandrine Espagne, MD d, Nadine Kacet, MD e, Genevieve Mouchnino, MD f, Serge Klosowski, MD g, Gérard Krim, MD h, Sandra Lescure, MD i, Stephane Le Bouedec, MD j, Pierre Meyer, MD b, Dominique Astruc, MD a, b
Reprint requests: Pierre Kuhn, MD, Médecine et Réanimation Néonatale, Service de Pédiatrie 2, Hôpital de Hautepierre, Centre Hospitalier Universitaire de Strasbourg, Avenue Molière 67098, Strasbourg, France.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) ≤ 32 weeks were included if they had a peripheral blood count showing < 1500 neutrophils/mm3 for at least 24 hours during the first 3 weeks of life. A total of 200 infants received either rG-CSF (10 μg/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.
Le texte complet de cet article est disponible en PDF.Mots-clés : AGA, ANC, BPD, CI, CLD, CRP, GA, GM-CSF, NEC, NI, rG-CSF, ROP, SD, SGA
Plan
| Supported by the Programme Hospitalier de Recherche Clinique National of the French Ministry of Health (020322). The authors declare no conflicts of interest. |
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| Registered at www.clinicaltrials.gov: NCT00213759. |
Vol 155 - N° 3
P. 324 - septembre 2009 Retour au numéro
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