EUCTR2016-002974-11-ES进行中（未招募）1 期
Phase III, randomized, multicenter, double-blind clinical trial to evaluate two echo-guided administration regimens of ibuprofen in the treatment of patent ductus arteriosus: impact on intestinal prognosis
María Carmen Bravo Laguna0 个研究点开始时间: 2016年9月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Preterm infants less than 33 weeks gestational age
- •2. PDA = 1.5 mm and medical decision to start drug treatment
- •3. Signed informed consent by the legal representative
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 180
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Consent Denied
- •2. Presence of severe birth defects
- •3. Congenital Heart Disease
- •4. Contraindication for administration of IB:
- •oligoanuria (diuresis <1 cc / kg / h)
- •recent severe intraventricular bleeding (IVH grade III or extensive periventricular hemorrhagic infarction)
- •Serum creatinine> 1.5 mg / dl or clinical suspicion of intestinal ischemia.
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