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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00213759
First received: September 13, 2005
Last updated: November 28, 2007
Last verified: November 2007
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

  Eligibility

Ages Eligible for Study:   up to 35 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213759

Locations
France
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
Investigators
Principal Investigator: Jean Messer, MD Hopitaux Universitaires de Strasbourg
  More Information

No publications provided by University Hospital, Strasbourg, France

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00213759     History of Changes
Other Study ID Numbers: 2712, 0203222
Study First Received: September 13, 2005
Last Updated: November 28, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
neutropenia
prematurity
nosocomial infection
G-CSF

Additional relevant MeSH terms:
Infection
Neutropenia
Cross Infection
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on September 30, 2014