Feasibility of Using Early CPAP (Continuous Positive Airway Pressure) And Large Volume Minimal Invasive Surfactant Therapy (ECALMIST) in Preterm Infants With Respiratory Distress Syndrome (RDS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 5
- 主要终点
- Incidence of Early Ventilation Hours
研究概览
简要总结
Modification of Minimally Invasive Surfactant Therapy (MIST) to a new technique called ECALMIST (Early CPAP And Large volume Minimal Invasive Surfactant). This modification is needed to adapt the use of large volume surfactant of 4-5 ml/kg.
The ECALMIST will be used to deliver the large volume Surfactant that been used in Canada called BLES (about 5 ml for each 100 mg) to the preterm infants bellow 35 weeks gestation suffer from respiratory distress syndrome (RDS) in 1st 24 hours of life while maintained on CPAP.
详细描述
The 5 ml/Kg surfactant is warm to room temperature. Using standard laryngoscope without premedication while the infant is maintained on continuous positive airway pressure (CPAP. The the laryngoscope should be removed after stabilizing the vascular catheter between 2 fingers at the level of lips (weight +6 cm). The surfactant will be administer by boluses of 0.25 -0.5 ml at a time over 20-30 seconds and 10 seconds apart while maintain the vital signs.
The procedure should be stopped if the vital signs deteriorate, CPAP pressure and oxygen requirement might need to adjusted to restore baseline vital signs. If the vital signs remained unstable the catheter should be removed and the infant managed according by positive pressure ventilation (PPV) or intubation by endotracheal tube (ETT).
At the end of the procedure the catheter should be flushed with 0.5 ml of air then catheter should be removed.
FiO2 (fraction of inspired oxygen), oxygen saturation and CPAP pressure will be recorded before during and after the procedure.
Complication like bradycardia (Hear rate below 100 beat per minute) or Apnea (pause of respiration for more than 20 second or less than 20 seconds but associated with bradycardia) All other neonatal outcome will be recorded (IVH [Intra-ventricular Hemorrhage], ROP [Retinopathy of prematurity], duration of ventilation, duration of hospital stay, infection, duration of oxygen requirement and others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Minutes 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants less than 35 weeks gestation in 1st day of life with RDS and spontaneously breathing on CPAP and need surfactant administration.
排除标准
- •Infants needs of mechanical ventilation
- •Congenital anomaly
- •Respiratory distress due to non RDS related causes.
- •no parental consent
结局指标
主要结局
Incidence of Early Ventilation Hours
时间窗: 72 hours
The need for mechanical ventilation due to various reasons like sepsis, Apnea (pause of respiration for more than 20 seconds) or Respiratory dysfunction evidenced by abnormal blood gas or desaturation or increase work of breathing
次要结局
- Incidence of Bradycardia During Procedure(Range of 10 minutes)
- Index Before the Procedure(1 hour)
- CPAP Pressure After the Procedure(4 hours)
- Oxygen Requirement Before the Procedure(1 hour)
- Oxygen Saturation After the Procedure(4 hours)
- Index After the Procedure(4 hours)
- CPAP Pressure Before the Proceudre(1 hour)
- Saturation During the Procedure(10 minutes)
- Failure to Catheterized the Trachea by the Vascular Catheter(20 seconds)
- Oxygen Saturation Before the Procedure(1 hour)
- Oxygen Requirements After the Procedure(4 hours)
- Needs for Intubation During the Procedure(10 minutes)
研究者
Yahya Al Ethawi
Principal Investigator MD
University of Manitoba