NCT06153771已完成不适用
Description of Changes in NIRS as a Function of Ductus Arteriosus Status in Very Premature Babies Born Before 32 WG at the DIJON University Hospital: Exploratory Prospective, Monocentric, Observational, Descriptive Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The ultrasound status of the ductus arteriosus
研究概览
简要总结
Monitoring patent ductus arteriosus is currently performed using echocardiography, an operator-dependent examination which requires holding the child on their back and which is potentially time-consuming. This test is usually carried out on days 2, 4 and 7 after birth.
NIRS (near-infrared spectroscopy) is a non-invasive method of monitoring tissue oxygen saturation using infrared light.
The aim of the study was to investigate an association between cerebral and renal NIRS data and ductus arteriosus status obtained by echocardiography.
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 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent who has agreed to participate in the study
- •Very premature newborn (born before 32 weeks' gestation)
- •Hospitalised in the Neonatal Intensive Care Unit at Dijon University Hospital
- •Before 48 hours of life
排除标准
- •Newborn with congenital heart disease
- •Newborn with a congenital renal anomaly
- •Newborn with polymalformative syndrome
- •Newborn with a skin anomaly
- •Newborn with severe circulatory failure unrelated to the ductus arteriosus
结局指标
主要结局
The ultrasound status of the ductus arteriosus
时间窗: On day 2, day 4 and day 7 of life
(haemodynamically significant open, non-haemodynamically significant open, closed)
次要结局
未报告次要终点
研究者
研究点 (1)
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