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Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF

This study has been completed.
Information provided by:
University Hospital, Strasbourg, France Identifier:
First received: September 13, 2005
Last updated: November 28, 2007
Last verified: November 2007
Prevention trial of nosocomial infections in neutropenic prematures with G-CSF

Condition Intervention Phase
Neutropenia in Prematures
Drug: filgrastim
Drug: dextrose 5%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF

Resource links provided by NLM:

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • survival without infection at 4 weeks after treatment [ Time Frame: one month ]

Secondary Outcome Measures:
  • survival free of infection at 2 weeks after treatment,mortality, increase of neutrophile, number of septic event, incidence of chronic lung disease, necrotizing enterocolitis, cerebral us abnormalities, retinopathy , duration of hospitalisation stay [ Time Frame: one month ]

Enrollment: 200
Study Start Date: March 2002
Study Completion Date: August 2006
Arms Assigned Interventions
Active Comparator: groupe filigrastin Drug: 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%.
Placebo Comparator: groupe placebo Drug: 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.


Ages Eligible for Study:   up to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

< 33 weeks GA neutropenic during at least 24 hours in the first 3 weeks of life and not infected at time of inclusion < 35 if birth weight < 1500 g

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Please refer to this study by its identifier: NCT00213759

Xavier Hernandorena
Bayonne, France
Alain Menget
Besancon, 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
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Jean Messer, MD Hopitaux Universitaires de Strasbourg
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00213759     History of Changes
Other Study ID Numbers: 2712
Study First Received: September 13, 2005
Last Updated: November 28, 2007

Keywords provided by University Hospital, Strasbourg, France:
nosocomial infection

Additional relevant MeSH terms:
Premature Birth
Cross Infection
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Leukocyte Disorders
Hematologic Diseases
Iatrogenic Disease
Disease Attributes
Pathologic Processes processed this record on April 26, 2017