Management of neonatal respiratory distress syndrome on the basis of Silverman Anderson score compared to standard care- a randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total duration of oxygen therapy in the two groups
研究概览
简要总结
STUDY WILL RECRUIT PRETERM NEWBORNS WITH RESPIRATORY DISTRESS SYNDROME . RECRUITS WILL BE ASIGNED INTO EITHER CONTROL OR TRIAL GROUP BY RANDOMIZATION . IN THE TRIAL GROUP SURFACTANT WILL BE ADMINISTERED USING A INFANT FEEDING TUBE . IN THE CONTROL GROUP SURFACTANT WILL BE ADMINISTERED BY INSURE METHOD . BOTH GROUP RDS WILL BE VALIDATED BY POINT OF CARE ULTRASOUND OF THE LUNGS AND PNEUMOTHORAX RULED OUT . DATA WILL BE COLLECTED AND ANALYSED FOR OUTCOME VARIABLES AND WHETERTHEY ARE SIGNIFICANT . .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 3.00 Day(s)（—）
- 性别
- All
入选标准
- •Gestational age of 28+0 to 34+6 Weeks 2 .
- •Haemodynamically stable 3 .
- •No visible congenital anomaly 4 .
- •Inborn babies.
排除标准
- •Gestational age below 28 weeks or above 35 weeks 2 .
- •Haemodynamically unstable 3 .
- •Any congenital anamoly 4 .
- •Pneumothorax 5 .
- •Intubated newborn since birth.
结局指标
主要结局
Total duration of oxygen therapy in the two groups
时间窗: When respiratory support is withdrawn after 1 week after admission and at transfer out / discharge from unit
次要结局
- 1. Mortality in two groups(2. Total duration of NICU stay)
研究者
Avik Banerjee
RAMAKRISHNA MISSION SEVA PRATISTHAN , VIVEKANANDA INSTITUTE OF MEDICAL SCIENCE