Back to resultsEffect of Recombinant Human Granulocyte Colony- Stimulating Factor on CD11b in Septic Neonates
Primary Purpose
Neonatal Sepsis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
rh-GCSF
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Sepsis
Eligibility Criteria
Inclusion Criteria:
- newborn infants with postnatal age < 28 day,
- minimum gestational age of 28 weeks and requiring intensive care with clinical signs consistent with the diagnosis of neonatal sepsis,
- with or without neutropenia
Exclusion Criteria:
- neonates with congenital malformation,
- major chromosomal abnormalities,
- prior use of cytokines or intravenous immunoglobulin, or decreased hemoglobin and/or hematocrit at or below the levels necessitate transfusion
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
No Intervention
Arm Label
control group
G-CSF group
Non-GCSF group
Arm Description
Outcomes
Primary Outcome Measures
all cause mortality
Secondary Outcome Measures
Full Information
NCT ID
NCT01479114
First Posted
November 21, 2011
Last Updated
November 24, 2011
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT01479114
Brief Title
Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on CD11b in Septic Neonates
Official Title
In Vivo Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on Neutrophilic Expression of CD11b in Septic Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aimed to evaluate the effect of G-CSF administration in septic neonates on neutrophil production and CD11b expression.
Detailed Description
Neonates are susceptible to septicemia secondary to quantitative and qualitative neutrophilic defects. Granulocyte-colony stimulating factor (G-CSF) stimulates myeloid progenitor cell proliferation and induces selective neutrophil functions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Title
G-CSF group
Arm Type
Experimental
Arm Title
Non-GCSF group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
rh-GCSF
Other Intervention Name(s)
Granulocyte colony stimulating factor,neubogen,filgstrim
Intervention Description
10 ug/kg/day intravenously for 3 days
Primary Outcome Measure Information:
Title
all cause mortality
Time Frame
one month
10. Eligibility
Sex
All
Maximum Age & Unit of Time
4 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
newborn infants with postnatal age < 28 day,
minimum gestational age of 28 weeks and requiring intensive care with clinical signs consistent with the diagnosis of neonatal sepsis,
with or without neutropenia
Exclusion Criteria:
neonates with congenital malformation,
major chromosomal abnormalities,
prior use of cytokines or intravenous immunoglobulin, or decreased hemoglobin and/or hematocrit at or below the levels necessitate transfusion
12. IPD Sharing Statement
Learn more about this trial
Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on CD11b in Septic Neonates
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