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NCT00213759 Clinical Trial

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

Neutropenia in Prematures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00213759
Other study ID # 2712
Secondary ID 0203222
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated November 28, 2007
Start date March 2002
Est. completion date August 2006

Study information
Verified date November 2007
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

Prevention trial of nosocomial infections in neutropenic prematures with G-CSF

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 35 Weeks
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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%.
• 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.

Locations
Country Name City State
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

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary survival without infection at 4 weeks after treatment one month
Secondary 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 one month