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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00213759

Enrollment

200

Registered

2005-09-21

Start date

2002-03-31

Completion date

2006-08-31

Last updated

2007-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neutropenia in Prematures

Keywords

neutropenia, prematurity, nosocomial infection, G-CSF

Brief summary

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

Interventions

DRUGfilgrastim

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%.

DRUGdextrose 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Days to 35 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
survival without infection at 4 weeks after treatment	one month

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026