Zekai Tahir Burak Maternity Teaching Hospital
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Duration of mechanical ventilation
研究概览
简要总结
Meconium aspiration syndrome (MAS) is an important cause of severe respiratory failure in newborn infants. Treatment for MAS is mainly supportive but surfactant therapy might change the course of the disease. Aim of the study to evaluate whether lung lavage with dilute or bolus poractant alfa changes the duration of mechanical respiratory support or other outcomes in MAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with a gestational age ≥ 36 weeks, birth weight ≥ 2.0 kg, evidence of passage of meconium at or before delivery, typical chest radiology findings and mechanically ventilated infants with a mean airway pressure ≥ 12 cm H2O were enrolled.
排除标准
- •Congenital cardiac anomalies
- •Major congenital anomalies
- •Hemodynamically unstable infants
研究组 & 干预措施
Bolus surfactant
Bolus surfactant 100 mg/kg proctant alfa
干预措施: Bolus surfactant (Drug)
Lung lavage with surfactant
Lung lavage with surfactant
干预措施: Lung lavage with surfactant (Drug)
结局指标
主要结局
Duration of mechanical ventilation
时间窗: up to 2 weeks
Total duration of mechanical ventilation, mode and ventilator parameters are noted till the baby is on mechanical ventilation.
次要结局
- Complications(up to 4 weeks)
- Duration of Hospital Stay(Up to 8 weeks or till discharge)
- Mortality(Up to 3 months or till discharge)
研究者
Mehmet Yekta
Zekai Tahir Burak Maternity and Teaching Hospital
Zekai Tahir Burak Women's Health Research and Education Hospital