Changes of Cerebral Tissue Oxygen Saturation During Treatment of Patent Ductus Arteriosus in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus
研究概览
简要总结
The purpose of this study is to examine the influence medical or surgical treatment for patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on cardiac output.
详细描述
In this observational trial the investigators want to examine whether clinical or echocardiographic parameters of patent ductus arteriosus are related to
- cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD
- renal tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD
as measured by near infrared spectroscopy
and to
- stroke volume
- cardiac output
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 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn infant below 34 weeks postmenstrual age at the time of birth
- •Patent ductus arteriosus with signs of hemodynamic relevance (as judged by the attending neonatologist)
- •parental informed consent
排除标准
- •Patent ductus arteriosus as part of malformation syndrome
- •Additional major cardiovascular malformations
研究组 & 干预措施
Indomethacin
Infants treated with Indomethacin
干预措施: Indomethacin (Drug)
Ibuprofen
Infants treated with Ibuprofen
干预措施: Ibuprofen (Drug)
Ligation
Infants undergoing surgical ligation
干预措施: Surgical Ligation (Procedure)
结局指标
主要结局
Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus
时间窗: from 10 minutes before start of infusion until 4 hours after end of transfusion
次要结局
未报告次要终点
研究者
Manuel Schmid
Dr. med.
University of Ulm