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
- 是
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
Petja Fister, MD, PhD
Principal Investigator, Petja Fister, MD, PhD
University Medical Centre Ljubljana
研究点 (1)
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