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临床试验/NCT00751959
NCT00751959已完成不适用

Surfactant Application During Spontaneous Breathing With CPAP or During Mechanical Ventilation in the Therapy of IRDS in Premature Infants < 27 Weeks

University of Cologne13 个研究点 分布在 1 个国家目标入组 213 人开始时间: 2009年4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
入组人数
213
试验地点
13
主要终点
Survival until term without CLD

研究概览

简要总结

This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.

详细描述

80 % of extremely preterm infants with a gestational age of less than 27 completed weeks suffer from severe idiopathic respiratory distress syndrome (IRDS). They are still at high risk of mortality and long term morbidity especially of the lung and the brain. At least death and chronic lung disease (CLD) are related to the need and the duration of mechanical ventilation. Continuous positive airway pressure (CPAP) has been shown to be effective to avoid mechanical ventilation in the treatment of IRDS but it often fails in the most immature infants. Early or prophylactic surfactant application is effective in the treatment of IRDS and is the only causal therapy, but it is usually related to intubation and mechanical ventilation that should be avoided.Therefore to overcome the dilemma between need for mechanical ventilation with surfactant administration on the one hand and surfactant withholding with the use of CPAP on the other hand, a strategy was developed to administer surfactant during spontaneous breathing with CPAP (1). In the proposed prospective randomised controlled trial this strategy shall be compared with the recent gold standard in the therapy of extremely preterm infants with IRDS, that is intubation, mechanical ventilation and surfactant administration. Based on the results of a feasibility (1) study and some clinical observations it is hypothesised that the new approach is superior in avoidance of death and chronic lung disease compared to the recent gold standard.

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
None

入排标准

年龄范围
23 Weeks 至 26 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • IRDS with Silverman-Score ≥ 5 and / or FiO2 ≥ 0,3
  • Postnatal age of more than 10 min. and less than 2 hours
  • Gestational age ≥ 23+0 and < 27+0

排除标准

  • Primary cardio- pulmonary resuscitation
  • Prenatally diagnosed severe malformation
  • No parental consent
  • Participation in another interventional trial

研究组 & 干预措施

2

Active Comparator

Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application

干预措施: Curosurf (Drug)

1

Experimental

Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP

干预措施: Curosurf (Drug)

结局指标

主要结局

Survival until term without CLD

时间窗: 13-17 weeks after birth

次要结局

  • Survival until term without CLD, IVH>II°, cystic PVL, ROP with need for surgery(13-17 weeks after birth)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Angela Kribs

MD

University of Cologne

研究点 (13)

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