A Multicenter, Randomized Trial of Preterm Infants Receiving Caffeine and Less Invasive Surfactant Administration Compared to Caffeine and Early Continuous Positive Airway Pressure (CaLI Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- Frequency of subjects requiring endotracheal intubation between the two groups (LISA vs CPAP) in the first 72 hours of life
研究概览
简要总结
This study is being conducted to determine whether prophylactic administration of surfactant by the Less Invasive Surfactant Administration (LISA) method reduces the need for mechanical ventilation in the first 72 hours of life when compared to early Continuous Positive Airway Pressure (CPAP) alone.
详细描述
In order to allow for initial stabilization on CPAP, infants will be randomized by 1 hour of life. Consented infants that are assessed by a provider as clinically stable (i.e. HR> 100 bpm) and spontaneously breathing on CPAP will be randomized by computer generated randomization cards placed in opaque envelopes.
Randomization will be stratified by gestational age (24-26+6 weeks and 27-29+6 weeks) and labeled as such on each envelope. Multiples will be randomized to the same treatment group for ease of consent and family considerations.
Infants randomized to LISA will receive surfactant (Curosurf 2.5 mL/kg, based on estimated fetal weight) and must be given in the first 2 hours of life using a conventional or video laryngoscope and a small flexible 16 gauge angiocatheter.
All sites have agreed on using senior level physicians or practitioners that have prior experience with the LISA method. An orogastric tube will be placed into the stomach prior to laryngoscopy and the contents aspirated after the procedure to document any esophageal surfactant administration.
Infants randomized to early CPAP will be managed according to unit practice for preterm infants on CPAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 24 Weeks 至 29 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants born at 24 to 29+6 weeks gestation
- •Informed consent obtained (antenatal)
- •Infant is spontaneously breathing on CPAP of 5-8 cmH2O and maintaining a normal heart rate (HR>100 Bpm)
排除标准
- •Declined consent
- •Infants with known congenital anomalies
- •Unstable immediately after birth, requiring intubation in the delivery room
结局指标
主要结局
Frequency of subjects requiring endotracheal intubation between the two groups (LISA vs CPAP) in the first 72 hours of life
时间窗: Within 72 hours of life
Required intubation or meeting respiratory failure criteria of having a pCO2 greater than 65 mm Hg or an FiO2 greater than 0.4 for more than 2 hours in the first 72 hours of life
次要结局
- Frequency of Grade III and IV intraventricular hemorrhage(Through study completion at discharge, up to 6 months of corrected gestational age)
- Neurodevelopment outcome at 2 Years of Age(22-26 months corrected gestational age)
- Need for repeat surfactant dosing(Up to 40 weeks of corrected gestational age)
- Duration of mechanical ventilation and/or CPAP(Through study completion at discharge, up to 6 months of corrected gestational age)
- Oxygen at 36 weeks corrected age(Up to 40 weeks of corrected gestational age)
- Neurodevelopment outcome at 24 months of corrected gestational age(Up to 2 years of corrected gestational age)
研究者
Anup Katheria, M.D.
Director of Neonatal Research Institute
Sharp HealthCare