Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on CD11b in Septic Neonates
This study has been completed.
Sponsor:
Ain Shams University
Information provided by (Responsible Party):
Rania Ali El-Farrash, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01479114
First received: November 21, 2011
Last updated: November 24, 2011
Last verified: November 2011
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Purpose
The investigators aimed to evaluate the effect of G-CSF administration in septic neonates on neutrophil production and CD11b expression.
| Condition | Intervention | Phase |
|---|---|---|
|
Neonatal Sepsis |
Drug: rh-GCSF |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | In Vivo Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on Neutrophilic Expression of CD11b in Septic Neonates |
Resource links provided by NLM:
MedlinePlus related topics:
Sepsis
Drug Information available for:
Filgrastim
Sargramostim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by Ain Shams University:
Primary Outcome Measures:
- all cause mortality [ Time Frame: one month ] [ Designated as safety issue: No ]
| Enrollment: | 90 |
| Study Start Date: | April 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: control group | |
| Experimental: G-CSF group |
Drug: rh-GCSF
10 ug/kg/day intravenously for 3 days
Other Name: Granulocyte colony stimulating factor,neubogen,filgstrim
|
| No Intervention: Non-GCSF group |
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.
Eligibility| Ages Eligible for Study: | up to 4 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Rania Ali El-Farrash, Dr., Ain Shams University |
| ClinicalTrials.gov Identifier: | NCT01479114 History of Changes |
| Other Study ID Numbers: | MREC 09030 |
| Study First Received: | November 21, 2011 |
| Last Updated: | November 24, 2011 |
| Health Authority: | Egypt: Ministry of Health, Drug Policy and Planning Center |
Additional relevant MeSH terms:
|
Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
Lenograstim Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013