Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Oxygen requirement
研究概览
简要总结
The incidence of pulmonary hemorrhage (PH) was about 1.3 per 1,000 live births. PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Although not clear, the cause of PH is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising results in treating PH.In this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.
详细描述
The incidence of PH was about 1.3 per 1,000 live births. Formerly,the risk factors associated with PH included the severity of the associated illness, intrauterine growth restriction, patent ductus arteriosus (PDA), coagulopathy, and the need for assisted ventilation. Currently, PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Currently, PH complicates the hospital course of 3-5% of preterm infants with RDS. The cause of PH is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising results in treating PH.In this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 1 Week(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants <1500 g
- •Within first week of life
排除标准
- •Major congenital abnormalities
- •Without parental consent
研究组 & 干预措施
Beractant
Beractant (Survanta): 100 mg/kg-intratracheal, just after pulmonary hemorrhage
干预措施: Poractant alfa (Drug)
Poractant alfa
Poractant alfa (Curosurf): 100 mg/kg-intratracheal, just after pulmonary hemorrhage
干预措施: Beractant (Drug)
结局指标
主要结局
Oxygen requirement
时间窗: 6 hour
We will evaluate the need of oxygen support within 6 hour after surfactant
次要结局
- Mortality(4 weeks)
研究者
Dilek Dilli
MD
Dr. Sami Ulus Children's Hospital
