To compare the need for mechanical ventilation between administration of surfactant by LISA and INSURE technique
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Need for mechanical ventilation in first 72 hours
研究概览
简要总结
This study is a open labelled, two parallel arm, randomized controlled trail comparing less invasive surfactant administration (LISA) with conventional INSURE method of surfactant administration in preterm neonates with respiratory distress syndrome. Primary outcome will be the need for mechanical ventilation within 72 hours of life. Secondary outcomes will be Requirement of repeat dose of surfactant, pneumothorax, early onset sepsis, duration of oxygen requirement, duration of hospital stay, apnea, bradycardia, or desaturation during surfactant administration, mortality.
LISA will be compared as a method to INSURE method for surfactant administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 0.00 Day(s) 至 1.00 Day(s)（—）
- 性别
- All
入选标准
- •Gestational age ≤ 34 weeks
- •Diagnosis of RDS based on clinical signs and confirmation by chest x ray findings and need for NIV support ( FiO2 >30 %; PEEP >6 H2O) to maintain saturation between 90% and 95% in the first 6 hours of life.
排除标准
- •Severe RDS been treated with endotracheal intubation
- •Major congenital malformation or complex CHD
- •Pulmonary haemorrhage
- •Cardiopulmonary failure
- •Congenital genetic metabolic disease
- •Gestational age less than 28 weeks
- •Transferred out of NICU with surgical treatment or other intervention.
结局指标
主要结局
Need for mechanical ventilation in first 72 hours
时间窗: First 72 hours after surfactant administration
次要结局
- Requirement of repeat dose of surfactant
- Pneumothorax(During hospitalisation)
- Early onset sepsis(72 hours)
- Duration of oxygen requirement(During hospitalisation)
- Duration of hospital stay(During hospitalisation)
- Apnea, bradycardia, or desaturation
- Mortality(During hospitalisation)