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临床试验/NCT04282369
NCT04282369Unknown不适用

Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress

Kanuni Sultan Suleyman Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Silverman Score

研究概览

简要总结

Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress

详细描述

In this study, it is aimed to search the efficacy and comfort of the four different non-invasive ventilation modes in the delivery room. HHFNC, NCPAP, NIPPV and NHFO modes are used for the respiratory distress of the late preterm and term babies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
— 至 2 Hours(Child)
性别
All
接受健康志愿者
否

入选标准

  • •late preterm and term infants with respiratory distress

排除标准

  • •intubation for the respiratory distres.
  • •major abnormalities

研究组 & 干预措施

HHFNC

Active Comparator

In this group patients will receive respiratory support by high flow nasal cannula.

干预措施: HHHFNC (Device)

nCPAP

Active Comparator

In this group patients will receive respiratory support by nasal CPAP.

干预措施: NCPAP (Device)

nIPPV

Active Comparator

In this group patients will receive respiratory support by nasal IPPV.

干预措施: NIPPV (Device)

nHFO

Active Comparator

In this group patients will receive respiratory support by nasal high frequency oscillatory. ventilation.

干预措施: NHFO (Device)

结局指标

主要结局

Silverman Score

时间窗: 6 months

The respiratory status of the newborns will be evaluated with the scoring system defined by Silverman.

次要结局

  • N-PASS score(6 months)

研究者

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

Ilker Gönen

Neonatologist

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (2)

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