Nasal Continuous Positive Airway Pressure in Preterm Infants After Extubation: Comparison of Different Levels of Pressure
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 主要终点
- The rate of successful extubation within 72 hours of extubation
研究概览
简要总结
Despite widely used of nasal CPAP in preterm infants, uncertainties regarding aspects of its application remain. Clinical indications vary greatly between institutions, especially when combined with varieties of systems, devices, and techniques available. One of the controversial aspects that needs to be clarified is the level of pressure which should be used. The objective of the study is to compare the effectiveness of two ranges of nCPAP pressure that are within the spectrum of current practice for post-extubation support in very preterm infants.
详细描述
The use of nCPAP has been established as an effective respiratory support to prevent extubation failure and as treatment of other pulmonary diseases. An upsurge in its popularity has resulted in some controversial aspects, including the level of pressure to be used. The level that has been used in very preterm infants after extubation, which mostly came from anecdotal data, varies from 3 to 10 cmH2O.
Physiologic studies show higher nCPAP pressures improve lung mechanical properties. Though potential side effects have been of concern in practical application, there is no formal evidence supporting the concept that increased CPAP pressure results in a higher risk of complications. In relatively stable preterm infants, the range of optimal CPAP level needs to be established in order to adequately support the upper airway and lungs, without increasing complications secondary to the pressure applied. Given the uncertainty of the nCPAP pressure that should be used in very preterm infants, we conduct a randomized controlled trial to compare the effectiveness of two ranges of nCPAP pressure for post-extubation support in very preterm infants.
The purpose of this trial is to compare the rate of successful extubation of using the nasal CPAP level of 7 to 9 cmH2O compared to level of 4 to 6 cmH2O.
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 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight 500 - 1,250 g
- •On mechanical ventilation before 7 days of age
- •First extubation before 14 days of age
排除标准
- •Presence of lethal anomalies or upper airway abnormalities
- •IVH, grade 3 or 4
- •Neuromuscular disorders
- •Receiving muscle relaxation at time of extubation
- •Congenital heart disease, except for PDA
- •GI problems resulting in a need to avoid gastric distension
结局指标
主要结局
The rate of successful extubation within 72 hours of extubation
时间窗: within 72 hours after extubation
次要结局
- The rate of successful extubation within 7 days of extubation(within 14 days after extubation)
- Number of days on nCPAP(within 14 days after extubation)
- Occurrence of air leak syndrome(within 14 days after extubation)
- Occurrence of IVH grade 3 or 4(within 14 days after extubation)
- Occurrence of traumatized nasal septum(within 14 days after extubation)