Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- percentage of neonates requiring mechanical ventilation
研究概览
简要总结
This study is designed to test an incidental finding of a previous trial in which post hoc analysis showed that the rate of intensive care newborns requiring mechanical ventilation was lower in the group receiving heparin with the continuous infusion as compared to the placebo group.
详细描述
Title: Randomized double blind trial comparing heparin and placebo as additives to continuous infusion in intensive care neonates for prevention of mechanical ventilation
Primary endpoint: Percentage of neonates requiring mechanical ventilation in both groups
Secondary endpoints: Duration of dependency on mechanical ventilation; major bleedings, incidence of heparin-induced thrombocytopenia and of anti-platelet factor 4/heparin antibodies
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns < day 28 of life
- •Necessity for intensive care treatment
- •Necessity for parenteral drug or fluid application for at least five days
- •Informed consent of parents
排除标准
- •Body weight < 500g
- •Mechanical ventilation directly after birth
- •Major malformations
- •Absolute indication for heparin
- •Inborn hemorrhagic disease (e.g. hemophilia, von Willebrand disease)
- •Cerebral bleeding or other major bleeding
- •Platelet count < 50,000/µl
结局指标
主要结局
percentage of neonates requiring mechanical ventilation
次要结局
- duration of dependency on mechanical ventilation
- major bleeding
- heparin induced thrombocytopenia
- anti PF4/heparin antibodies