RPCEC00000099招募中4 期
Evaluation of effectiveness and safety of SURFACEN early use for the Newborn Respiratory Distress Syndrome. Phase IV
ational Center for Animal Plant and Health (CENSA)0 个研究点开始时间: 2011年4月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
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
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment
入排标准
- 年龄范围
- no 至 2 hours old（—）
- 性别
- All
入选标准
- •1. Newborn of less than 2 hours 2. Gestational age between 26-36 weeks, both inclusive 3. Patients who meet the criteria of early use of SURFACEN 4. Patient's mother (and/or Patient's father) who expressed voluntarily the participation in the study with the signature of the Informed Consent
排除标准
- •1. Major congenital malformations 2. Severe infections 3. Bronchoaspiration of the meconial amniotic liquid 4. Intrapartum asphyxia 5. Pneumothorax or pneumomediastinum before the beginning of the treatment with SURFACEN. 6. Pulmonary hemorrhage before the beginning of the treatment with SURFACE
研究者
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