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

Phase 3CompletedNCT00213759

University Hospital, Strasbourg, France200 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

200

Conditions

Neutropenia in Prematures

Interventions

filgrastimDRUG

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%DRUG

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

Sex: ALLMin age: 2 DaysMax age: 35 Weeks

Medical Language ↔ Plain English

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

Locations (9)

Xavier Hernandorena

Bayonne, France

Alain Menget

Besançon, France

Jean-Louis Demarquez

Bordeaux, France

Bernard Guillois

Caen, France

Outcomes

Primary Outcomes

survival without infection at 4 weeks after treatment

Time frame: one month

Secondary Outcomes

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

Data from ClinicalTrials.gov

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