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临床试验/NCT03411018
NCT03411018已完成不适用

The Impact of Modifications on Respiratory Management of Preterm Infants on the Death or Bronchopulmonary Dysplasia Outcome

Manuel Sanchez Luna1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
1
主要终点
BRONCHOPULMONARY DySPLASIA

研究概览

简要总结

This observational study evaluates the impact of respiratory management modifications implemented in our institution on the intubation rates and the death or Bronchopulmonary Dysplasia (BPD) outcome.

详细描述

Less invasive respiratory management has been implemented in most neonatal units as well as lung protective ventilatory strategies when intubation is required in order to minimize ventilator induced lung injury.

In our institution a new ventilatory protocol including less invasive surfactant administration, Synchronized nasal positive pressure ventilation and early rescue High frequency ventilation has been implemented during 2013-14.

Hypothesis

New less invasive and lung protective strategies to prevent lung injury had been effective in reducing intubation rates.

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
— 至 36 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • All preterm Infants born with less than 32wGA admitted in our NICU.

排除标准

  • Congenital malformations and Known Chromosomal disorders,

结局指标

主要结局

BRONCHOPULMONARY DySPLASIA

时间窗: 36 weeks of postmenstrual age.

Diagnosis of moderate-severe bronchopulmonary dysplasia (physiological definition)

mortality

时间窗: before discharge

death

次要结局

  • Mechanical ventilation(during hospitalization)

研究者

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

Manuel Sanchez Luna

Head of Neonatology, Clinical Professor

Hospital General Universitario Gregorio Marañon

研究点 (1)

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