FAST TRIAL 2 - Fourier-transform Infrared Spectroscopy(FTIR) Guided Surfactant Therapy - RCT
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 380
- 试验地点
- 7
- 主要终点
- Survival without moderate to severe bronchopulmonary dysplasia (BPD)
研究概览
简要总结
Recently the investigators have developed a point of care test (LS-test) to measure surfactant as lecithin in gastric aspirates from preterm infants.
This test can be done immediately at delivery and potentially be used to guide surfactant treatment.
To obtain evidence-based knowledge on harms and benefit of surfactant therapy guided by the L/S test, a randomized clinical trial with relevant clinical short-and long-term outcomes needs to be performed, which is why the FAST 2 Trial has been designed.
详细描述
Treatment of respiratory distress syndrome (RDS) has evolved greatly over the past three decades. Major advances in treatment include antenatal steroids, early nasal continuous positive airway pressure (nCPAP) combined with early rescue surfactant replacement strategies such as Intubation Surfactant Extubation (INSURE) and Less Invasive Surfactant Administration (LISA), together with use of lung protective ventilation and overall reduced use of mechanical ventilation. However, RDS and bronchopulmonary dysplasia (BPD) are still major causes of mortality and morbidity in premature infants. To improve the outcome, very early treatment with surfactant is necessary. However, only about half of infants with a gestational age (GA) below 30 weeks need surfactant treatment and prophylactic surfactant treatment increases the combined mortality and incidence of BPD contrary to selective rescue surfactant treatment. Therefore, there is a need for a rapid test to guide early targeted surfactant treatment.
The investigators have recently developed a new test of lung maturity based on measuring the lecithin sphingomyelin ratio (L/S) in fresh gastric aspirates (GAS) from newborn preterm infants using mid-red Fourier Transform Infrared spectroscopy (FTIR). The sphingomyelin concentration in amniotic fluid and accordingly in GAS is relatively constant during the pregnancy, whereas the lecithin (or dipalmitoylphosphatidylcholine (DPPC), the lung surfactant phospholipid with the highest surface activity) concentration increases with the lung maturation.
It has been demonstrated in clinical observational trials that this laboratory based L/S-test predicts development of RDS when measured immediately at delivery (FAST 1 Trial).
The L/S-test has now been developed into an easy-to-use Point of Care (POC) test for bedside use that expresses the L/S ratio in approximately 10 minutes. It is believed this new POC test can be used to guide surfactant therapy, enabling very early rescue treatment, potentially even before symptoms occur.
To obtain evidence-based knowledge on harms and benefit of surfactant therapy guided by the L/S test, a randomized clinical trial with relevant clinical short-and long-term outcomes needs to be performed, which is why the FAST 2 Trial has been designed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
It is not possible to blind LS-guided surfactant treatment in the interventional group, but the actual result of the LS-test will remain blinded for both groups until completion of the study except for as detailed above.
入排标准
- 年龄范围
- — 至 45 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GA ≤ 29+6, inborn at a participating centre
- •Age less than 45 minutes as GAS must be sampled within 45 minutes from delivery.
排除标准
- •Treated with surfactant before randomisation and obtaining gastric aspirates
- •Diagnosis of major malformations (major congenital heart defects, congenital diaphragmatic hernia, gastroschisis/omphalocele, pulmonary abnormalities including pulmonary hypoplasia and trachea-oesophageal fistula
- •Antenatal suspicion of significant oligohydramnios and lung hypoplasia
- •Any intrauterine intervention except if done for genetic testing
结局指标
主要结局
Survival without moderate to severe bronchopulmonary dysplasia (BPD)
时间窗: at 36 weeks PMA or discharge withever comes first
BPD is defined as per a modified "NIH definition" in which any degree of respiratory support for at least 28 days is considered equal to the need for oxygen: * Treatment with oxygen \> 21% or any degree of respiratory support for a least 28 days plus * Need for treatment with oxygen \> 21% or any degree of respiratory support at PMA 36 weeks or at discharge, whichever comes first. Definitions: * Moderate BPD is defined as treatment with oxygen \> 21% or any degree of respiratory support for a least 28 days plus need of supplemental oxygen from \>21% to \< 30% (as low flow O2) at 36+0 weeks PMA * Severe BPD is defined as treatment with oxygen \> 21% or any degree of respiratory support for a least 28 days plus need of \> 30% oxygen and/or continuous need for any level of respiratory support providing positive airway pressure (nHFT, nCPAP, NIV or mechanical ventilation)
次要结局
- mortality(From date of birth until the date of death if this happens before discharge)
- Intraventricular hemorhage(From date of birth to 44 weeks of gestational age (usually around 18 weeks))
- Airleak(From date of birth to 44 weeks of gestational age (usually around 18 weeks))
- LS-ratio(72 hours)
- number of surfactant treatments,(72 hours)
- surfactant treatment,(72 hours)
- surfactant treatmentdose,(72 hours)
- gastric aspirate obtained(72 hours)
- Nectrotizing enterocolitis(From date of birth to 44 weeks of gestational age (usually around 18 weeks))
- Spontaneous intestinal perforation(From date of birth to 44 weeks of gestational age (usually around 18 weeks))
- timing surfactant treatments,(72 hours)
- gastric aspirate analyzed(72 hours)
- Bronchopulmonary dysplasia(at 36 weeks PMA or discharge withever comes first)
研究者
Christian Heiring
Principal Investigator
Rigshospitalet, Denmark