EUCTR2015-004526-33-IE进行中（未招募）1 期
A Randomised Controlled Trial of Early Targeted Patent Ductus Arteriosus Treatment Using a Risk Based Severity Score - PDA RCT
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
- 60
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
- •All infants less than 29 weeks admitted to the NICU with a PDA identified on echocardiography between 36 and 48 hours of life will be eligible for inclusion. A comprehensive assessment of PDA significance will be performed using echocardiography to derive a PDA risk score based on this following formula: Infants with a risk score = 5.0 are deemed to be at high risk of developing CLD/Death and will be randomised to either arm
- •(Gestation in weeks × -1.304) + (PDA diameter in mm × 0.781) + (Left ventricular output in ml/kg/min × 0.008) + (maximum PDA velocity in m/s × -1.065) + (LV a` wave in cm/s × -0.470) + 41, where 41 is the constant of the formula.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •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
- •The following infants will be excluded:
- •lack of consent or study investigators
- •lethal congenital abnormality or obvious syndrome
- •pulmonary hypoplasia
- •active bleeding
- •known or suspected NEC
- •platelet count < 100/mm2
- •creatinine > 100 µmol/L; neutropenia
- •oliguria < 1ml/kg/hour
- •congenital heart disease other than a PDA or a patent foramen ovale
- •grade 3 or higher IVH
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