NCT00213759已完成3 期
Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF
University Hospital, Strasbourg, France9 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2002年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- survival without infection at 4 weeks after treatment
研究概览
简要总结
Prevention trial of nosocomial infections in neutropenic prematures with G-CSF
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Days 至 35 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 33 weeks GA neutropenic during at least 24 hours in the first 3 weeks of life and not infected at time of inclusion < 35 if birth weight < 1500 g
排除标准
- 未提供
研究组 & 干预措施
groupe filigrastin
Active Comparator
干预措施: filgrastim (Drug)
groupe placebo
Placebo Comparator
干预措施: dextrose 5% (Drug)
结局指标
主要结局
survival without infection at 4 weeks after treatment
时间窗: one month
次要结局
- survival free of infection at 2 weeks after treatment,mortality, increase of neutrophile, number of septic event, incidence of chronic lung disease, necrotizing enterocolitis, cerebral us abnormalities, retinopathy , duration of hospitalisation stay(one month)
研究者
研究点 (9)
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