EUCTR2015-003177-14-ES进行中（未招募）1 期
Paracetamol versus ibuprofen in preterm infants with a hemodynamically significant patent ductus arteriosus: a randomized clinical trial.
未提供0 个研究点开始时间: 2016年4月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •? Informed consent signed by parents or legal representative.
- •? Gestational age ? 30 weeks.
- •? Postnatal age ? 2 weeks
- •? 1st episode of hemodynamically significant PDA diagnosed by ultrasound:
- •1. Continuous flow through DAP.
- •2. Retrograde diastolic flow in the descending aorta.
- •3. Strain the left atrium. (relationship left atrium / aorta (LA / AO)> 1.5).
- •4. Ductal diameter greater than 1.7 mm.
- •5. Relationship ductus / descending aorta diameter size greater than 0.5.
- •? Need for ventilatory support
- •? Born in participating hospitals or coming to them in the application of the treatment period
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 396
- •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
- •- Gestational age> 30 weeks
- •- Postnatal age> 2 weeks
- •- Major congenital malformations.
- •- Impending doom.
- •- Chromosomopaties.
- •- Refusal to participate and / or sign the informed consent.
- •- Inability to randomization or scrambling wrong.
- •- Participation in another clinical trial
- •- Diuresis less than 1 ml / kg / h for 8 h prior to treatment
- •- Greater than 1.8 mg / dl Creatinine
- •- Platelets below 50,000 / uL
- •- Active bleeding (tracheal, gastrointestinal and renal)
- •- Intraventricular hemorrhage recently (48h) (grades 3-4)
- •- Severe hyperbilirubinemia
- •- Liver failure or severe coagulopathy
- •- Active necrotizing enterocolitis or intestinal perforation
- •- Septic shock
研究者
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