Surfactant Administration by Insure or Thin Catheter
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Mechanical ventilation
研究概览
简要总结
This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy. It will provide valuable knowledge to improve clinical methodology and enhance lung protective treatment strategies for preterm infants.
详细描述
To compare two approaches for surfactant administration during CPAP in preterm infants, the INSURE and the LISA technique, using premedication intubation protocols, and investigate aspects of safety, stress and pain, timely administration of the drug, response in oxygenation and pulmonary outcome.
Our study asks whether (P) among infants born <32 weeks' gestation with RDS (I) does surfactant administration with LISA and analgesia premedication (C) versus surfactant administration according to the INSURE protocol (O) improve oxygenation and reduce the rate of respiratory failure and need for intubation and mechanical ventilation (T) within 48 hours of the procedure
Primary outcomes:
- Positive effect: Oxygenation measured as arterial to alveolar ratio (a/A ratio) at 24 hours post-procedure.
- Negative effect: Need for mechanical ventilation (MV) within 48 hours post-procedure.
Safety outcomes:
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 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born before 32 completed weeks of gestation on CPAP, with clinical and radiological signs of RDS and need for surfactant treatment.
排除标准
- •Infants requiring surfactant as part of delivery room resuscitation are not eligible.
- •Infants will be excluded from the final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: congenital diaphragmatic hernia; tracheo-oesophageal fistula or cyanotic heart disease.
结局指标
主要结局
Mechanical ventilation
时间窗: 48 hours post-procedure
Need for intubation and mechanical ventilation (MV)
Oxygenation
时间窗: 24 hours post-procedure
Arterial to alveolar ratio (a/A ratio)
次要结局
- Length of stay(Discharge)
- Mortality(Discharge)
- Duration of ventilatory support(Discharge)
- Complications(Discharge)
研究者
Kajsa Bohlin
MD, PhD
Karolinska Institutet