Prevention Trial of Nosocomial Infectio… | Clinical Trial

Key information

Conditions

Neutropenia in Prematures Agranulocytosis Cross Infection Cytopenia Disease Attributes Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Iatrogenic Disease Infections Leukocyte Disorders Leukopenia Neutropenia Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Urogenital Diseases

Age range

2 day–35 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Xavier Hernandorena, Bayonne, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Filgrastim

Drug

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.

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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Important dates

Study start: 2002
Study completion: 2006
First posted: Sep 21, 2005
Registry last updated: Nov 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed