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临床试验/NCT01860014
NCT01860014已完成不适用

Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage

Dr. Sami Ulus Children's Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Beractant (Survanta): 100 mg/kg-intratracheal, just after pulmonary hemorrhage

干预措施: Poractant alfa (Drug)

Poractant alfa

Active Comparator

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

发起方
Dr. Sami Ulus Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Dilli

MD

Dr. Sami Ulus Children's Hospital

研究点 (1)

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