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

PHASE3CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

March 31, 2002

Study Completion Date

August 31, 2006

Conditions
Neutropenia in Prematures
Interventions
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%.

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.

Trial Locations (9)

Unknown

Xavier Hernandorena, Bayonne

Alain Menget, Besançon

Jean-Louis Demarquez, Bordeaux

Bernard Guillois, Caen

Marie Thieuleux, Calais

André Labbe, Clermont-Ferrand

Jean-Bernard Gouyon, Dijon

Pierre Andrini, Grenoble

Jean Messer, Strasbourg

All Listed Sponsors
lead

University Hospital, Strasbourg, France

OTHER

NCT00213759 - Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF | Biotech Hunter | Biotech Hunter