Surfactant Application During Spontaneous Breathing With CPAP or During Mechanical Ventilation in the Therapy of IRDS in Premature Infants < 27 Weeks
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
- 否
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
Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application
干预措施: Curosurf (Drug)
1
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)
