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临床试验/NCT02449863
NCT02449863已完成不适用

Lung Ultrasound as a Predictor of Mechanical Ventilation in Neonates Older Than 32 Weeks

Hospital Sant Joan de Deu2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
2
主要终点
investigate whether LUS performed during the first 2 hours of life is a useful tool to predict respiratory failure of neonates older than 32 weeks with respiratory distress

研究概览

简要总结

Neonatal respiratory distress prognosis may be difficult to estimate at admission. Lung ultrasound is a useful diagnostic tool that is quick, requires little training and is radiation free. This study analyzes whether early lung ultrasound can predict respiratory failure.

详细描述

Neonatal respiratory distress prognosis may be difficult to estimate at admission. Lung ultrasound is a useful diagnostic tool that is quick, requires little training and is radiation free. This study analyzes whether early lung ultrasound can predict respiratory failure.

Methods This study was conducted from January to December 2014 at Hospital Sant Joan de Déu (Esplugues de Llobregat, Barcelona, Spain), a third-level hospital with 3300 births per year and a neonatal intensive care unit with annual admission of 700 patients.

Local institutional review board of Hospital Sant Joan de Déu approved the protocol (project approval number PIC-07-15) and written informed consent was obtained from all parents.

Patients older than 32 weeks admitted to the neonatal intensive care unit with respiratory distress who were not on invasive mechanical ventilation (MV) were eligible for recruitment.

A single operator, a neonatologist skilled in lung and heart sonography, performed the examinations. Images were then analysed by another neonatologist with less experience in LUS. He was blind to the perinatal history and chest radiography of the newborns and unaware of the clinical diagnosis. Infants were from a non-consecutive convenience sample recruited when the operator was available for the execution of LUS in the first 2 hours of life.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
32 Weeks 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 32 weeks admitted to the neonatal intensive care unit with respiratory distress who were not on invasive mechanical ventilation (MV) were eligible for recruitment.

排除标准

  • Patients younger than 32 weeks
  • Patients with mechanic ventilation ar admission

结局指标

主要结局

investigate whether LUS performed during the first 2 hours of life is a useful tool to predict respiratory failure of neonates older than 32 weeks with respiratory distress

时间窗: 2 hours of life

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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