Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA): Comparison to High Flow Nasal Cannula (HFNC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Duration of Oxygen Use
研究概览
简要总结
This study is to evaluate the feasibility of using a pressure limited nasal cannula system instead of a high flow nasal cannula system in the management of premature babies with respiratory distress.
详细描述
NCPAP has been used increasingly to manage respiratory distress in newborns as well as apnea of prematurity. Humidified high flow nasal cannula devices (flows 1-8 lpm) have also been used in neonatal intensive care units.
This study is to evaluate the feasibility of using a pressure limited nasal cannula system instead of a high flow nasal cannula system in the management of premature babies with respiratory distress.
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
- 23 Weeks 至 40 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates admitted to NICU
- •Weights of 400-500 grams
- •Requiring oxygen greater than 30%
- •No evidence of focal lobar consolidation in lung fields
排除标准
- •Intolerance to procedure
- •gelatinous skin
- •known allergy to adhesive material
- •interference with therapy
- •profound sepsis
- •pneumonia
- •unmanaged apnea/bradycardia
- •known or suspect complex congenital heart disease
- •severe cleft lip or palate
- •suspect or proven lethal congenital anomaly
- •intolerance to the interface used in the devices
- •inability to secure an appropriate fit of the patient nasal interface
- •considered non-viable or of uncertain viability
- •parental refusal.
研究组 & 干预措施
High flow nasal cannula system w/ ADINA
The intervention is the insertion of the the ADINA device into the high flow nasal cannula system. ADINA will be placed according to weight class recommendations to increase the positive end expiratory pressure (PEEP). ADINA is actually a combination of the Neotech RAM Cannula and a clear Regulator/Pop off valve.
干预措施: Adaptive Dynamic Inspiratory Nasal Apparatus (Device)
high flow nasal cannula system
High flow nasal cannula will deliver oxygen at 2-4 lpm of flow. High flow cannula are used to provide the control interface.
干预措施: High flow Nasal Canula (Device)
结局指标
主要结局
Duration of Oxygen Use
时间窗: From time of randomization until time of discharge from the Neonatal Intensive Care Unit (NICU) up to 100 days.
The length of time the patient is on oxygen will be measured in hours.
次要结局
- Number of Participants with Excoriation at Nasal Site(From time of randomization until time of discharge from NICU up to 100 days.)
- Oxygen Concentration(From time of randomization until time of discharge from NICU up to 100 days.)
- Number of Participants with treatment-related pneumothorax(From time of randomization until time of discharge from NICU up to 100 days.)