Pilot Study to Evaluate the Usefulness of Liver Regional Oxygen Saturation (RSO2) in Preterm Patent Ductus Arteriosus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Day 14 liver regional oxygen saturation
研究概览
简要总结
This study evaluates the usefulness of liver perfusion and oxygenation status using regional oxygen saturation (RSO2) values obtained via near-infrared spectroscopy in assessing the hemodynamical significance of patent ductus arteriosus in preterm infants.
详细描述
The usefulness of cerebral and renal regional oxygen saturation (RSO2) values for assessing hemodynamically significant patent ductus arteriosus (hsPDA) has been described previously. Meanwhile, autoregulation of the splanchnic organs' perfusion is less developed compared to the cerebral and renal system, which makes the splanchnic bed more prone to perfusion decrease and ischemia in cases of volume depletion or poor circulation. If RSO2 is measure in the liver, the solid organ reflecting the splanchnic bed perfusion status, hsPDA may be more readily identified than when only cerebral and/or renal RSO2 is monitored.
This study aims to evaluate the usefulness of liver RSO2 measurement in assessing the hemodynamical significance of patent ductus arteriosus in preterm infants, in comparison to cerebral and renal RSO2.
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
- — 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age at birth less than 32 weeks
- •Birthweight less than 1,500 grams
排除标准
- •Major congenital anomaly
- •chromosomal / genetic anomaly
结局指标
主要结局
Day 14 liver regional oxygen saturation
时间窗: 14 (±3) days after birth
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
Day 2 liver regional oxygen saturation
时间窗: 48 to 72 hours of birth
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
Day 7 liver regional oxygen saturation
时间窗: 7 (±2) days after birth
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
次要结局
- PDA liver regional oxygen saturation(When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, up to 28th day of life)
研究者
Sook Kyung Yum
Dr. Sook Kyung Yum
Seoul St. Mary's Hospital