EUCTR2017-001376-28-NL进行中（未招募）1 期
Multi-center, randomized non-inferiority trial of early treatment versus expectative management of patent ductus arteriosus in preterm infants. - BeNeDuctus Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 564
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
- •- Gestational age < 28 completed weeks
- •- Postnatal age < 72 hours
- •- PDA diameter > 1.5 mm and ductal (predominantly) left-to-right shunt
- •- Signed informed consent obtained from parent(s) or representative(s)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 564
- •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
- •- Contraindication for administration of cyclooxygenase-inhibitors (COXi)
- •- Use of COXi prior to randomization
- •- Persistent pulmonary hypertension (ductal right-to-left shunt ?33% of cardiac cycle)
- •- Congenital heart defect, other than PDA and/or PFO
- •- Life-threatening congenital defects
- •- Chromosomal abnormalities and/or congenital anomalies associated with abnormal neurodevelopmental outcome
研究者
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