Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on CD11b in Septic Neonates
Phase 4
Completed
- Conditions
- Neonatal Sepsis
- Interventions
- Drug: rh-GCSF
- Registration Number
- NCT01479114
- Lead Sponsor
- Ain Shams University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description G-CSF group rh-GCSF -
- Primary Outcome Measures
Name Time Method all cause mortality one month
- Secondary Outcome Measures
Name Time Method