Evaluation of the Efficacy of Different Surfactant Preparations in Preterm Infants by Lung Ultrasound
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Lung usg scores
研究概览
简要总结
To compare the lung ultrasound scores after two different natural surfactant administration as a parameter reflecting lung inflation. Poractant alfa decreases lung ultrasound scores as efficient as beractant treatment
详细描述
Outcomes:
Improvement of Lung usg scores after surfactanct and the difference between groups at different time points (2nd and 6hr).
Secondary outcome:
The correlation between lung usg scores and clinical scores (silverman scores), FiO2 and PCO2 levels, failure of weaning to noninvasive ventilation after surfactant Preterm infants of 32 gestational weeks and below, who admit to the NICU with signs of respiratory distress, treated with non invasive or mechanical ventilation and require surfactant treatment in 6 hours of life will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants of 32 gestational weeks and below, who admit to the NICU with signs of respiratory distress, treated with non invasive or mechanical ventilation and require surfactant treatment in 6 hours of life will be enrolled.
排除标准
- •major congenital anomalies.
研究组 & 干预措施
group 1 Poractant alfa
Poractant alfa generic name: curosurf 120 and 240 mg flk dosage: 200 mg/ kg intratracheal application frequency and duration: in the first two hours
干预措施: group 1 Poractant alfa (Device)
group 2 beractant
beractant generic name: survanta 8 cc flk dosage: 4 cc/ kg intratracheal application frequency and duration: in the first two hours
干预措施: group 2 beractant (Device)
结局指标
主要结局
Lung usg scores
时间窗: first days
Evaluation of Lung Usg Scores in infants treated with surfactant in the first six hours (Brat lung usg scores). Each item scored 0-3. (0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.) - Higher values represent a worse outcome
次要结局
未报告次要终点