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

University Hospital, Strasbourg, France

Status and phase: Completed; Phase 3

Conditions: Neutropenia in Prematures

Treatments: Drug: dextrose 5%; Drug: filgrastim

Study type: Interventional

Funder types: Other

Identifiers

NCT00213759

2712

0203222

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: All

Ages: 2 days to 35 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

groupe filigrastin

Active Comparator group

Treatment:

Drug: filgrastim

groupe placebo

Placebo Comparator group

Treatment:

Drug: dextrose 5%