Back to resultsPrevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF
Primary Purpose
Neutropenia in Prematures
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
filgrastim
dextrose 5%
Sponsored by
About this trial
This is an interventional prevention trial for Neutropenia in Prematures focused on measuring neutropenia, prematurity, nosocomial infection, G-CSF
Eligibility 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
Sites / Locations
- Xavier Hernandorena
- Alain Menget
- Jean-Louis Demarquez
- Bernard Guillois
- Marie Thieuleux
- André Labbe
- Jean-Bernard Gouyon
- Pierre Andrini
- Jean Messer
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
groupe filigrastin
groupe placebo
Arm Description
Outcomes
Primary Outcome Measures
survival without infection at 4 weeks after treatment
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00213759
First Posted
September 13, 2005
Last Updated
November 28, 2007
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT00213759
Brief Title
Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF
Official Title
Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
5. Study Description
Brief Summary
Prevention trial of nosocomial infections in neutropenic prematures with G-CSF
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia in Prematures
Keywords
neutropenia, prematurity, nosocomial infection, G-CSF
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
groupe filigrastin
Arm Type
Active Comparator
Arm Title
groupe placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
filgrastim
Intervention Description
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%.
Intervention Type
Drug
Intervention Name(s)
dextrose 5%
Intervention Description
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 Outcome Measure Information:
Title
survival without infection at 4 weeks after treatment
Time Frame
one month
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Messer, MD
Organizational Affiliation
Hopitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xavier Hernandorena
City
Bayonne
Country
France
Facility Name
Alain Menget
City
Besancon
Country
France
Facility Name
Jean-Louis Demarquez
City
Bordeaux
Country
France
Facility Name
Bernard Guillois
City
Caen
Country
France
Facility Name
Marie Thieuleux
City
Calais
Country
France
Facility Name
André Labbe
City
Clermont-Ferrand
Country
France
Facility Name
Jean-Bernard Gouyon
City
Dijon
Country
France
Facility Name
Pierre Andrini
City
Grenoble
Country
France
Facility Name
Jean Messer
City
Strasbourg
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
19467544
Citation
Kuhn P, Messer J, Paupe A, Espagne S, Kacet N, Mouchnino G, Klosowski S, Krim G, Lescure S, Le Bouedec S, Meyer P, Astruc D. A multicenter, randomized, placebo-controlled trial of prophylactic recombinant granulocyte-colony stimulating factor in preterm neonates with neutropenia. J Pediatr. 2009 Sep;155(3):324-30.e1. doi: 10.1016/j.jpeds.2009.03.019. Epub 2009 May 24.
Results Reference
derived
Learn more about this trial
Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF
We'll reach out to this number within 24 hrs