- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01479114
Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on CD11b in Septic Neonates
November 24, 2011 updated by: Rania Ali El-Farrash, Ain Shams University
In Vivo Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on Neutrophilic Expression of CD11b in Septic Neonates
The investigators aimed to evaluate the effect of G-CSF administration in septic neonates on neutrophil production and CD11b expression.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 4 weeks (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
|
|
Experimental: G-CSF group
|
10 ug/kg/day intravenously for 3 days
Other Names:
|
No Intervention: Non-GCSF group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
all cause mortality
Time Frame: one month
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
November 21, 2011
First Submitted That Met QC Criteria
November 22, 2011
First Posted (Estimate)
November 24, 2011
Study Record Updates
Last Update Posted (Estimate)
November 28, 2011
Last Update Submitted That Met QC Criteria
November 24, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MREC 09030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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