Is it Possible to Premature Newborns Treated With Less Invasive Surfactant Administration Under Heated Humidified High-flow Air With Nasal Cannula?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Investigation of the effect of surfactant treatment on the p02 value in blood gases using the LISA method in premature babies with spontaneous breathing during different respiratory support.
研究概览
简要总结
Nasal Continuous Airway Pressure (CPAP) or Heated humidified high-flow Air support with nasal cannula (HHHFNC) are among the most commonly used non-invasive respiratory support methods. The purpose of this prospective study was to compare vital findings, blood gas parameters, perfusion index (PI) and plethysmographic variability index (PVI) values in premature infants treated with less invasive surfactant administration (LISA) under HHHFNC or CPAP.
详细描述
Nasal Continuous Airway Pressure (CPAP) or Heated humidified high-flow Air support with nasal cannula (HHHFNC) are among the most commonly used non-invasive respiratory support methods. The purpose of this prospective study was to compare vital findings, blood gas parameters, perfusion index (PI) and plethysmographic variability index (PVI) values in premature infants treated with less invasive surfactant administration (LISA) under HHHFNC or CPAP. This study was carried out in Hacettepe University Hospital NICU between January and December 2017. Premature newborns who were on noninvazive respiratory support and were diagnosed as RDS within first 72 hours of life, were taken into the study. Noninvasive respiratory support was provided with nasal CPAP or HHHNFC. Pulse oxymetry measurements were obtained before and 5th, 30th, 60th, 120th , 360th minutes, blood gas analysis was performed immediately before and 120th, 360th minutes after surfactant administration.
Post-hoc, one-way difference between two independent means (two groups) statistical analysis was used. Significance P < 0.05; effect size 0.9; power (1-ß err prob) was found to be 82%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Does not require intubation,
- •Diagnosed with RDS
- •Premature newborns receiving surfactant therapy in the first 72 hours of life
- •Those whose families give written consent
排除标准
- •Babies whose families do not give written consent
- •Newborns diagnosed with early neonatal sepsis
- •Newborns with inotropic requirements
- •Neonates with hemodynamically significant PDA
- •Babies of diabetic mothers
- •Babies with a major congenital anomaly
- •Newborns with hemodynamic instability,
- •Those requiring endotracheal intubation,
- •NEC (Stage 2 or higher),
- •Those showing ICH (Stage 2 or higher)
- •Babies with perfusion disorders in the first three days
结局指标
主要结局
Investigation of the effect of surfactant treatment on the p02 value in blood gases using the LISA method in premature babies with spontaneous breathing during different respiratory support.
时间窗: 360 minutes after surfactant treatment
A total of 34 premature babies were included in the study. There were 22 patients in the CPAP group and 12 patients in the HHHFNC group. It was planned to make a comparison between CPAP and HHHNFC groups in terms of bloog gas parameters before, during and after surfactant treatment. Blood gas analysis was performed immediately before and 120th, 360th minutes after surfactant administration. p02 values in blood gas were determined according to the routine protocol of our NICU. They were performed three times: immediately before the surfactant treatment and at the 120th and 360th minute after the surfactant was administered.
次要结局
- Investigation of the effect of using surfactant treatment with the LISA method during different respiratory support on the pulse oximetry parameters of babies.(360 minutes after surfactant treatment)
研究者
MELEK BUYUKEREN
Associate Professor
Hacettepe University