High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation as Initial Mode of Ventilation for Congenital Diaphragmatic Hernia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Oxygenation Index (OI) at 24 hours of age
研究概览
简要总结
The purpose of this study is to conduct a prospective study of all congenital diaphragmatic hernia (CDH) neonates managed at the University of Utah newborn intensive care unit (NICU) and Primary Children's Hospital NICU that required mechanical ventilation at birth. As both high frequency jet ventilation (HFJV) and high frequency oscillatory ventilation (HFOV) are standard approaches to ventilatory support of all neonates including CDH, CDH infants will be randomized at the time of birth or admission to either HFJV or HFOV as initial ventilator mode, stratified by position of the liver in the abdomen or thorax (if known) by 24 hours of age. Measures of oxygenation, ventilation and hemodynamics of the CDH cohort managed on HFOV compared to those on HFJV.
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
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to either the University of Utah and/or Primary Children's Hospital NICU within 24 hours of birth
- •Requiring mechanical ventilation
- •Umbilical arterial line or peripheral arterial line in place
- •Obtained signed consent
- •Infant is ≤ 24 hours of age
排除标准
- •Severe anomaly
- •Chromosomal abnormalities
- •Major congenital anomalies, including cardiac, central nervous system and syndromes
- •Post-natal diagnosis > 24 hours of life
- •Unable to obtain consent for participation
- •Unable to randomize within 24 hours of life
结局指标
主要结局
Oxygenation Index (OI) at 24 hours of age
时间窗: 24 hours of age
The OI will be measured at 24 hours of age using a standard of care arterial blood gas and oxygen settings. These measurements will then be compared between the stratified groups
次要结局
- PF ratio (PaO2/FiO2) measurements(up to one week)
- PF-PCO2 (PaO2/FiO2-PaCO2) measurements(up to one week)
- Number of babies who received inhaled nitric oxide (iNO)(up to one week)
- PaCO2 measurements(up to one week)
研究者
Michelle Yang
Principal Investigator
University of Utah