NCT01479114已完成4 期
In Vivo Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on Neutrophilic Expression of CD11b in Septic Neonates
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- all cause mortality
研究概览
简要总结
The investigators aimed to evaluate the effect of G-CSF administration in septic neonates on neutrophil production and CD11b expression.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
G-CSF group
Experimental
干预措施: rh-GCSF (Drug)
结局指标
主要结局
all cause mortality
时间窗: one month
次要结局
未报告次要终点
研究者
Rania Ali El-Farrash
Dr.
Ain Shams University
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