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临床试验/NCT02628821
NCT02628821已完成不适用

Effectiveness of Synchronized Non-Invasive Ventilation to Prevent Invasive Mechanical Ventilation Use in Preterm Infants.

Hospital General Universitario Gregorio Marañon1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Avoid of Invasive Mechanical Ventilation in the next three days.

研究概览

简要总结

Prospective observational study of SNIPPV use in preterm infants of less than 32weeks of gestation from January 2012 to December 2015. Previous respiratory status is analyzed as well as respiratory outcomes and possible secondary side effects.

SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants that met intubation criteria) and also is used electively for extubation when nCPAP extubation has previously failed or infants with Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).

详细描述

SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants that met intubation criteria) and also is used electively for extubation when nCPAP extubation has previously failed or infants with Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
1 Minute 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm Infants of less than 32 weeks of GA in which SNIPPV is applied for nCPAP failure.
  • Preterm Infants of less than 32 weeks of GA in which SNIPPV is applied electively for extubation.

排除标准

  • 未提供

结局指标

主要结局

Avoid of Invasive Mechanical Ventilation in the next three days.

时间窗: through study completion, an average of 1 year

The rate of infants treated with non-invasisive ventilation that do not need to be intubated in the next three days.

次要结局

  • Time on MV(through study completion, an average of 1 year)
  • Neurological impairment(through study completion, an average of 1 year)
  • Rate of patients with air leaks(through study completion, an average of 1 year)

研究者

发起方
Hospital General Universitario Gregorio Marañon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manuel Sanchez Luna

Dr.

Hospital General Universitario Gregorio Marañon

研究点 (1)

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