A randomised controlled trial in preterm infants comparing prophylactic with selective “Less Invasive Surfactant Administration” (pro.LISA)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 698
- 试验地点
- 23
- 主要终点
- Forced expiratory volume within the first second (... Forced expiratory volume within the first secoForced expiratory volume within the first second (FEV1) at 5 years of age (Global Lung Function Initiative z-score).
研究概览
简要总结
The aim of the pro.LISA study is to clarify the question of whether prophylactic use of surfactant in premature infants with a gestational age of 25 weeks + 0 days to 30 weeks + 6 days leads to an improved forced expiratory volume within the first second (FEV1) at the age of 5 years. The aim of the pro.LISA study is to clarify the question of whether prophylactic use of surfactant in preterm infants with a gestational age of 25 weeks + 0 days to 30 weeks + 6 days leads to an improved forced expiratory volume within the first second (FEV1) at the age of 5 years.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Preterm infants with a gestational age of 25+0 to 30+6 weeks of pregnancy
- •Age <= 60 minutes
- •Spontaneous breathing on CPAP
- •Pulse oximetrically measured saturation >=90% with a FiO2 <= 30%
- •Written informed consent of the legal guardian(s) (retrospectively if necessary)
排除标准
- •Malformations or diseases with a probable lethal outcome
- •Hypersensitivity to surfactant, sodium hydrogen carbonate or sodium chloride
结局指标
主要结局
Forced expiratory volume within the first second (... Forced expiratory volume within the first secoForced expiratory volume within the first second (FEV1) at 5 years of age (Global Lung Function Initiative z-score).
Forced expiratory volume within the first second (... Forced expiratory volume within the first secoForced expiratory volume within the first second (FEV1) at 5 years of age (Global Lung Function Initiative z-score).
次要结局
- At the age of 5 years: (1) FVC z-score, (2) FEV1/FVC z-score, (3) walking distance in the 3-minute walk test, (4) obstructive bronchitis treated with medication in the last 12 months, (5) cerebral palsy, defined as Gross Motor Function Classification System values > 1, (6) values in the Movement Assessment Battery for Children score, (7) intelligence quotient, determined with the WPPSI IV
研究者
Prof. Dr. Wolfgang Göpel
Scientific
Universitaetsklinikum Schleswig-Holstein AöR