Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Oxygen Saturation Index
研究概览
简要总结
Point-of-care ultrasound (POCUS) is the use of ultrasound by the bedside provider in real time to answer a specific question and guide medical management. POCUS can be used to diagnose the severity of neonatal respiratory distress syndrome (RDS) through a lung ultrasound score. Lung ultrasound scores have also been shown to predict if an infant is treated with an initial dose of surfactant. Therefore, using lung ultrasound scores to guide surfactant therapy for RDS will likely lead to earlier surfactant therapy and may improve short-term respiratory outcomes. This study will test this theory by comparing lung ultrasound score-guided surfactant therapy for premature infants with RDS with our current surfactant administration guidelines.
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
- 0 Hours 至 2 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The infant's parent/legal guardian can understand and willingly sign a written informed consent document for this study
- •Birth gestational age between 27w0d-36w6d
- •Diagnosis of respiratory failure secondary to RDS requiring respiratory support with non-invasive positive pressure ventilation
排除标准
- •Unable to obtain lung ultrasound between 1-2 hours of life
- •Infants already intubated or received surfactant before the point of care lung ultrasound
- •Infants born with congenital cardiac disease, congenital lung disease, or congenital facial/airway malformations
- •Infants born with chromosomal abnormalities
- •Infants with APGARs ≤ 5 at 10 minutes of life
- •Infants requiring cardiopulmonary resuscitation or therapeutic hypothermia in the first 6 hours of life
研究组 & 干预措施
Treatment
The treatment group will receive surfactant therapy if the initial LUS at 1-2 hours of life is > 9 or if they meet our unit's current surfactant therapy guidelines (irrespective of the LUS).
干预措施: Echography-guided Surfactant THERapy (ESTHER) (Diagnostic Test)
Control
The control group will receive surfactant therapy based on our unit's current surfactant guidelines, including but not limited to a FiO2 requirement ≥ 0.3 on non-invasive positive pressure ventilation.
结局指标
主要结局
Oxygen Saturation Index
时间窗: At 24 hours of life.
(CPAP Level x FiO2)/(SpO2)
次要结局
- Oxygen Saturation Index(At 48 and 72 hours of life.)
研究者
Jacob
Neonatal-Perinatal Fellow
Connecticut Children's Medical Center