Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants
研究概览
简要总结
The primary aim of this study is to quantify and compare changes in lung volumes (as measured by functional residual capacity) in premature infants stable on continuous positive airway pressure (CPAP), and then randomized to two additional weeks of CPAP and room air versus room air alone. We hypothesize that infants randomized to additional CPAP will demonstrate an increased functional residual capacity (at the end of the two week study period and prior to discharge) compared to those randomized to room air.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age at birth <33 weeks
- •Required CPAP for a minimum of 24 hours for respiratory distress
- •Patient on CPAP and room air at time of randomization
排除标准
- •Complex congenital heart disease other than patent ductus arteriosus or atrial septal defect
- •Major malformations or chromosomal anomalies
- •Multiple gestation greater than twins
- •Culture proven sepsis or unstable at time of randomization
研究组 & 干预措施
Room air
Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
CPAP and room air
Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.
干预措施: CPAP and room air (Device)
结局指标
主要结局
Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants
时间窗: Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).
Functional residual capacity (FRC) was measured with the nitrogen washout technique. For the nitrogen washout technique, calibration is done with 2 known volumes, and a calibration line was constructed for the system at the specific flow rate and used to correlate the nitrogen washed out to the infant's FRC. The system corrected for dead space and corrected the FRC to body temperature, pressure, and water-saturated conditions. Acceptance criteria included: 1) infant supine and quietly asleep; 2) test initiated at end expiration; 3) no evidence of leak on tracing of the washout; 4) consistent tracings; 5) at least 2-3 measurements with a coefficient of variation \<10%. These are testing and acceptance criteria outlined by the American Thoracic Society and European Respiratory Society.
次要结局
- Measurements of Passive Respiratory Compliance in Randomized Premature Infants(Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age)
- Passive Respiratory Resistance in Randomized Premature Infants(Just prior to randomization, two weeks after randomization, and at discharge at about 35-37 weeks of corrected gestational age.)
- Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants.(Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age.)
研究者
Cynthia McEvoy
Professor of Pediatrics
Oregon Health and Science University