Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF
NCT ID: NCT00213759
Last Updated: 2007-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2002-03-31
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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groupe filigrastin
filgrastim
The G-CSF (filigrastin) will be administered by intravenous way with the amount of 10 µg/kg/day during 3 days . The infusion will last from 20 to 40 minutes according to weight of the child and the product will be diluted in dextrose 5%.
groupe placebo
dextrose 5%
The placebo (dextrose 5% ) will be injected by intravenous way with the amount of 0.66 ml/kg during 3 days consecutive. The infusion will last from 20 to 40 minutes.
Interventions
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filgrastim
The G-CSF (filigrastin) will be administered by intravenous way with the amount of 10 µg/kg/day during 3 days . The infusion will last from 20 to 40 minutes according to weight of the child and the product will be diluted in dextrose 5%.
dextrose 5%
The placebo (dextrose 5% ) will be injected by intravenous way with the amount of 0.66 ml/kg during 3 days consecutive. The infusion will last from 20 to 40 minutes.
Eligibility Criteria
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Inclusion Criteria
2 Days
35 Weeks
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Principal Investigators
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Jean Messer, MD
Role: PRINCIPAL_INVESTIGATOR
Hopitaux Universitaires de Strasbourg
Locations
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Xavier Hernandorena
Bayonne, , France
Alain Menget
Besançon, , France
Jean-Louis Demarquez
Bordeaux, , France
Bernard Guillois
Caen, , France
Marie Thieuleux
Calais, , France
André Labbe
Clermont-Ferrand, , France
Jean-Bernard Gouyon
Dijon, , France
Pierre Andrini
Grenoble, , France
Jean Messer
Strasbourg, , France
Countries
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References
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Kuhn P, Messer J, Paupe A, Espagne S, Kacet N, Mouchnino G, Klosowski S, Krim G, Lescure S, Le Bouedec S, Meyer P, Astruc D. A multicenter, randomized, placebo-controlled trial of prophylactic recombinant granulocyte-colony stimulating factor in preterm neonates with neutropenia. J Pediatr. 2009 Sep;155(3):324-30.e1. doi: 10.1016/j.jpeds.2009.03.019. Epub 2009 May 24.
Other Identifiers
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0203222
Identifier Type: -
Identifier Source: secondary_id
2712
Identifier Type: -
Identifier Source: org_study_id