Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Alveolar Volume
研究概览
简要总结
This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing.
详细描述
This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing. CPAP is a treatment widely used in the NICU in preterm infants right after they are born to help keep their lungs open/inflated. Although the benefit of CPAP after birth has been well studied, no one knows how long a stable preterm infant should stay on CPAP. The primary outcome of this study is to compare the lung volumes in the infants at 6 months of age by pulmonary function testing who were randomized to 2 extra weeks of CPAP in the NICU versus CPAP discontinuation, usual care. During the same pulmonary function test the investigators will also measure and compare how the infant's lungs diffuse gas.
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
- 1 Day 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at >24 to ≤ 32 weeks gestation
- •Treated with CPAP for ≥ 24 hours for respiratory distress (either as initial therapy or following extubation)
排除标准
- •Significant congenital heart disease
- •Major malformations
- •Chromosomal anomalies
- •Culture proven sepsis at consent
- •Complex maternal medical conditions
- •Clinical instability
- •Multiple gestations > twins
- •<3rd or >97th percentile for weight85
- •Participating in another neonatal randomized clinical trial with a competing outcome
- •Mother/legal guardian without stable method of communication
结局指标
主要结局
Alveolar Volume
时间窗: 4 - 8 months of age
Establish that 2 additional weeks of CPAP in the NICU for stable preterm infants changes alveolar volume at approximately 6 months of age compared to infants who have CPAP discontinued, usual care. Measurements of alveolar volume were obtained at the same time as measurements of lung diffusion using an induced respiratory pause technique at an elevated lung volume of 30 cmH2O. During the passive expiration following the 4 second induced respiratory pause for gas exchange, carbon monoxide (CO) and helium (He) concentrations are used to calculate alveolar volume and lung diffusion. Results were expressed as averages of 2-3 measurements within 10%, adjusting for hemoglobin.
次要结局
- Forced Expiratory Flows at 50% of the Expired Volume (FEF50)(4 - 8 months of age)
- Lung Diffusion(4 - 8 months of age)
研究者
Cynthia McEvoy
Principal Investigator
Oregon Health and Science University