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临床试验/NCT03558737
NCT03558737终止不适用

Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants

University of Utah4 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
4
主要终点
72 Hour Rate of Reintubation to Invasive Mechanical Ventilation

研究概览

简要总结

Very low birth weight infants are at increased risk of requiring prolonged duration of mechanical ventilation and multiple intubations, both of which are risk factors for ventilator-induced lung injury and BPD. Thus, it is important to investigate respiratory support methods that are able to effectively oxygenate and ventilate these high risk preterm infants while reducing their risk of lung injury. Nasal high-frequency ventilation is one potential intervention that may decrease the risk of respiratory failure in very low birth weight infants. Small studies have shown effective respiratory support over short time periods in infants, however these studies use nasal high-frequency oscillatory ventilation. To the investigators' knowledge there is no published studies looking at the use of nasal high-frequency jet ventilation in this high risk population.

Use of non-invasive high frequency ventilation (HFV) has been described as a rescue method following failure of other non-invasive ventilator modes or as a means to increase the success post-extubation. When used as invasive high frequency ventilation, high frequency oscillatory ventilation (HFOV) or high frequency jet ventilation (HFJV) utilize supraphysiologic respiratory rates and small tidal volumes which has been shown to inflict less lung injury than conventional modes of ventilation.

Using a mechanical newborn lung model, nasal HFV has improved CO2 removal when compared to conventional NIPPV. Animal studies in the lab of Kurt Albertine have shown improved ventilation and oxygenation in the high frequency nasal ventilation group versus the mechanical ventilation group in a preterm lamb model leading towards better alveolar formation noted histologically.

The investigators hypothesize that extubation of very preterm infants to nHFJV will significantly decrease the rates of reintubation compared to those infants extubated to NIPPV.

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 72 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • 24 0/7 to 28 6/7 weeks GA
  • Intubated within 24 hours of life to synchronized intermittent mandatory ventilation (SIMV) or high frequency ventilation (HFV, includes HFOV or HFJV)
  • Plan for extubation within 72 hours of life
  • Infants intubated for surfactant replacement therapy via INSURE method (Intubation-Surfactant-Extubation) are eligible
  • Consent obtained from parent/legal guardian

排除标准

  • Major congenital and/or chromosomal anomalies
  • Upper oropharyngeal anomalies

结局指标

主要结局

72 Hour Rate of Reintubation to Invasive Mechanical Ventilation

时间窗: 72 hours

The number of participants who needed to be reintubated during the first 72 hours of initiation of study intervention will be compared between both arms.

次要结局

  • Rates of Moderate to Severe Bronchopulmonary Dysplasia (BPD)(6 to 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bradley Yoder

Principal Investigator

University of Utah

研究点 (4)

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