JPRN-C000000405已完成3 期
Randomized, double-blind, placebo-controlled multi center clinical trial for the prevention of chronic lung disease in extremely low birth weight infants with inhaled fluticasone propionate - Randomized, double-blind, multi center clinical trial for the prevention of chronic lung disease in extremely low birth weight infants with inhaled fluticasone propionate
eonatal Research Network Japan0 个研究点目标入组 211 人开始时间: 2006年4月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 211
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 0weeks-old(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)Subjects with sepsis, pneumonia or severe acute infection (2)Subjects with severe liver dysfunction. (3)Subjects with suspected immunodeficiency or abnormal adrenal function. (4)Subjects with uncontrollable hyperglycemia (5)Subjects with uncontrollable hypertension (6)Subjects with severe malformation, highly suspected chromosomal abnormality (7)Subjects with renal dysfunction. (8)Subjects judged by the investigator to be inappropriate as study subjects.
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