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临床试验/NCT03411512
NCT03411512已完成不适用

Tissue Oxygenation in Newborns With Congenital Heart Defects

Petja Fister, MD, PhD1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2012年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
rSO2

研究概览

简要总结

Congenital Heart Defects and NIRS

详细描述

Brain, kidney and intestinal tissue oxygenation in newborns with congenital heart defects assessed by near-infrared spectroscopy.

研究设计

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

入排标准

年龄范围
1 Day 至 4 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Investigators included term newborns with critical structural CHD (of different types) who required surgical or transcatheter procedure in the first year of life. CHD were diagnosed by pediatric cardiologist by clinical examination and echocardiography.

排除标准

  • The exclusion criteria were pulmonary or neurological disease, perinatal asphyxia, acute illness, prematurity and congenital abnormality other than CHD.

结局指标

主要结局

rSO2

时间窗: RSO2 values were obtained after 30 minute calm down period to enable stable recordings on each channel by averaging five minutes recorded values.

regional tissue oxygenation assessed by NIRS

次要结局

未报告次要终点

研究者

发起方
Petja Fister, MD, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Petja Fister, MD, PhD

Principal Investigator, Petja Fister, MD, PhD

University Medical Centre Ljubljana

研究点 (1)

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Congenital Heart Defects and NIRS | 临床试验