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

Phase 3

Completed

• Conditions: Neutropenia in Prematures
• Interventions: Drug: dextrose 5%; Drug: filgrastim

• Registration Number: NCT00213759
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2006-08
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-28
• Last Update Posted: 2007-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
groupe placebo	dextrose 5%	-
groupe filigrastin	filgrastim	-

Primary Outcome Measures

Name	Time	Method
survival without infection at 4 weeks after treatment	one month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

André Labbe; 🇫🇷 Clermont-Ferrand, France

Alain Menget; 🇫🇷 Besancon, France

Marie Thieuleux; 🇫🇷 Calais, France

Jean-Louis Demarquez; 🇫🇷 Bordeaux, France

Xavier Hernandorena; 🇫🇷 Bayonne, France

Jean-Bernard Gouyon; 🇫🇷 Dijon, France

Pierre Andrini; 🇫🇷 Grenoble, France

Bernard Guillois; 🇫🇷 Caen, France

Jean Messer; 🇫🇷 Strasbourg, France