Effects of Bolus Surfactant Therapy on Serial Peripheral Perfusion Index and Tissue Carbon Monoxide Measurements in Preterm Infants With Severe Respiratory Distress Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change from baseline in perfusion index (PI)at 6 hours
研究概览
简要总结
Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in premature infants, which is also associated with inflammation. There are different types and doses of surfactant preparations available. With the help of new generation monitors, changes in peripheral perfusion and transcutaneous CO, a marker of inflammation, may be demonstrated.
详细描述
Preterm infants with severe Respiratory Distress Syndrome (study group) were compared to preterm infants without Respiratory Distress Syndrome(control group). Infants in the study group were randomized to receive either poractantalfa or beractant.
Perfusion index (PI) and transcutaneous CO (TCO) values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- — 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 26 and 36 weeks
- •intubated for respiratory distress syndrome
排除标准
- •cardiac defects,
- •hemodynamically significant patent ductusarteriosus,
- •congenital pneumonia,
- •early sepsis
- •unstable infants in need of inotropic support.
研究组 & 干预措施
poractantalfa
preterm infants who received poractantalfa for respiratory distress syndrome
干预措施: exogenous surfactant (Drug)
beractant
preterm infants who received beractant for respiratory distress syndrome
干预措施: exogenous surfactant (Drug)
结局指标
主要结局
Change from baseline in perfusion index (PI)at 6 hours
时间窗: before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life
PI values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.
Change from baseline in transcutaneous carbon monoxide (TCO)at 6 hours
时间窗: before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life
TCO values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.
次要结局
未报告次要终点
研究者
Mehmet Yalaz
Attending Neonatologist
Ege University