RPCEC00000163已完成3 期
Evaluation of the efficacy and safety of SURFACEN in the treatment of Acute Respiratory Distress Syndrome in pediatric patients
ational Center for Animal and Plant Health (CENSA)0 个研究点目标入组 72 人开始时间: 2013年6月21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
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 28 days 至 18 years(—)
- 性别
- All
入选标准
- •1. Presence of ARDS within 72 hours of diagnosis, 2. PEEP> 5 cm H2O. 3. Patients whose parents / guardians give their written consent to participate in the study. 4. Aged 28 days old and 18 years inclusive.
排除标准
- •1. Onco-hematological diseases. 2. Chronic heart disease (ventricular septal defect, atrial septal defect, patent ductus arteriosus, pulmonary stenosis, coarctation of the aorta, aortic stenosis, tetralogy of Fallot, transposition of great arteries, tricuspid atresia and truncus). 3. Hypersensitivity to the surface or other component of the formulation.
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