临床试验/NCT03081611

NCT03081611已完成不适用

RAM Cannula for Delivering Nasal Intermittent Positive Pressure Ventilation (NIPPV) in Preterm Infants: Non Inferiority Randomized Control Trial

Rambam Health Care Campus2 个研究点分布在 1 个国家目标入组 166 人开始时间: 2018年1月1日最近更新: 2020年2月18日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Rambam Health Care Campus
入组人数: 166
试验地点: 2
主要终点: intubation

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants

详细描述

Randomized control trial comparing Ram cannula to the regular, more investigated short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants with respiratory distress.

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

盲法说明

Not possible

入排标准

年龄范围: — 至 28 Days（Child）
性别: All
接受健康志愿者: 否

入选标准

•Gestational age 24-33.6
•Physician decision on the need for non invasive ventilation
•parental consent

排除标准

•Pneumothorax before recruitment
•Significant congenital heart disease or chromosomal disorder

结局指标

主要结局

intubation

时间窗: 72 hours

The need for intubation

次要结局

nasal trauma(during NIPPV procedure)

研究者

发起方

Rambam Health Care Campus

申办方类型

Other

责任方

Principal Investigator

主要研究者

Ori Hochwald , MD

Principal Investigator

Rambam Health Care Campus

研究点 (2)

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