Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP
研究概览
简要总结
This study will seek to enroll neonates requiring Nasal Continuous Airway Pressure (NCPAP) respiratory support and randomize them to either oscillatory (Osc-NCPAP, study group) or non-oscillatory (NCPAP, control group) mode. The goal of the research is to determine if Osc-NCPAP provides improved ventilation support compared to routine NCPAP, i.e. NCPAP without oscillations. This will be measured by need for change to ventilator support, improvement in pCO2 values, and reduction in respiratory rate and frequency of apnea during the period of NCPAP treatment. Other respiratory outcomes will also be compared, including time on NCPAP, time on High-Flow Nasal Cannula support following NCPAP, and time-averaged PiO2 from start of study to end of respiratory treatment.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Newborn (0-28 days of age) admitted to Neonatal Intensive Care Unit (NICU)
- Ordered respiratory treatment of NCPAP
排除标准
- Major congenital defect
- Known or suspected chromosomal disorder
研究组 & 干预措施
Nasal CPAP
Standard Nasal CPAP
干预措施: Nasal CPAP (Device)
Oscillatory NCPAP
NCPAP will be given to infant via prongs in the infant's nose. A Bird Industries pneumatic oscillating diaphragm to drive a Bird Industries phasatron which is attached by T-connector to the NCPAP patient circuit.
干预措施: Oscillatory NCPAP (Device)
结局指标
主要结局
Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP
时间窗: 2 months
Determine the physiologic respiratory stability (pCO2, respiratory rate, apnea frequency) during treatment with NCPAP
Need for mechanical ventilation following the initiation of NCPAP.
时间窗: 2 months
The rate of mechanical ventilation following both Oscillating and Non-Oscillating groups.
次要结局
- Total duration of non-invasive and invasive respiratory support in each study group.(2 months)
- total amount of oxygen exposure in each study group. Total amount of oxygen exposure in each study group.(2 months)
研究者
研究点 (3)
标识符
- NCT 编号
- NCT01277874
- 其他研究编号
- 36738
日期
- 首次提交
- (15年前)
- 首次发布
- (15年前)
- 主要完成日期
- (9年前)
- 研究完成日期
- (9年前)
- 最近核实
- (9年前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否