Plasma Biomarkers for the Prediction of Bronchopulmonary Dysplasia and Volumetric Capnography for Severity Assessment of Lung Disease in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- association of plasma biomarker levels (pro-endothelin-1 precursor and other markers of respiratory distress) with the duration of supplemental oxygen dependancy in infancy
研究概览
简要总结
The purpose of this study is to assess the association of biomarkers on day 7 of life with the development of bronchopulmonary dysplasia in very preterm infants. Additionally a short lung function test at 36 weeks postmenstrual age (PMA) will be performed to investigate whether certain capnographic indices are able to reflect the degree of lung disease.
Protocol was amended (under others: additional enrollment of 70 subjects).
详细描述
This is a two-centre prospective cohort study in very preterm infants born below 32 0/7 weeks PMA and hospitalised in the neonatal intensive care units at the University Children's Hospital Basel and the Inselspital Berne during two years. After informed consent a sample of 0.5 mL ethylenediaminetetraacetic acid (EDTA) full blood will be taken on day 7 of life (+/- 2 days) during routine blood sampling. The biomarkers which are planned to measure include the C-terminal portion of the proendothelin-1 precursor (CT-proendothelin (proET)-1) and other plasma biomarkers of respiratory distress. At 36 weeks PMA, lung function testing will be performed during quiet unsedated sleep in supine position approximately 30 minutes post feeding. After placement of a facemask, tidal breathing will be recorded at the bedside using a commercially available ultrasonic flow meter (Spiroson, Exhalyzer D, Ecomedics, CH) according to American Thoracic Society (ATS) and European Respiratory Society (ERS) standards of infant lung function testing. Different capnographic indices will be calculated to investigate if they reflect the degree of lung disease at 36 weeks PMA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Days 至 9 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •parental consent, born below 32 weeks PMA
排除标准
- •No parental consent, major life-threatening anomalies (cardiac defects, primary pulmonary malformations etc.)
结局指标
主要结局
association of plasma biomarker levels (pro-endothelin-1 precursor and other markers of respiratory distress) with the duration of supplemental oxygen dependancy in infancy
时间窗: Assessment at 36 weeks PMA or until the end of supplemental oxygen dependancy assessed up to 12 months
association of capnographic indices with the duration of supplemental oxygen dependancy
时间窗: 36 weeks PMA or until the end of supplemental oxygen dependancy assessed up to 12 months
Capnographic indices include expired carbon dioxide volume per breath, slopes of phase II (SII) and slopes of phase III (SIII) of the capnogram.
次要结局
- duration of respiratory support(participants will be followed for the duration of hospital stay, an expected average of 12 weeks)
- sepsis(participants will be followed for the duration of hospital stay, an expected average of 12 weeks)
- several definitions of BPD(36 weeks PMA)
- death(participants will be followed for the duration of hospital stay, an expected average of 12 weeks)
- necrotizing enterocolitis (NEC)(participants will be followed for the duration of hospital stay, an expected average of 12 weeks)
- intraventricular hemorrhage (IVH)(participants will be followed for the duration of hospital stay, an expected average of 12 weeks)
- patent ductus arteriosus(participants will be followed for the duration of hospital stay, an expected average of 12 weeks)
- retinopathy of prematurity (ROP)(until completion of retinal vascularization or up to 6 months, whichever came first)