NL-OMON47250已完成不适用
Multi-center, randomized non-inferiority trial of early treatment versus expectative management of patent ductus arteriosus in preterm infants. - BeNeDuctus Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 435
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •- Gestational age < 28 completed weeks
- •- PDA diameter > 1.5 mm and ductal (predominantly) left-to-right shunt
- •- Signed informed consent obtained from parent(s) or representative(s)
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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