Biomarkers and Volumetric Capnography in BPD

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Plasma Biomarkers for the Prediction of Bronchopulmonary Dysplasia and Volumetric Capnography for Severity Assessment of Lung Disease in Preterm Infants

Conditions
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Bronchopulmonary Dysplasia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: parental consent, born below 32 weeks PMA Exclusion Criteria: No parental consent, major life-threatening anomalies (cardiac defects, primary pulmonary malformations etc.)

Ages Eligible for Study
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Minimum Age: 5 Days
Maximum Age: 9 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| association of plasma biomarker levels (pro-endothelin-1 precursor and other markers of respiratory distress) with the duration of supplemental oxygen dependancy in infancy |  | 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 | Capnographic indices include expired carbon dioxide volume per breath, slopes of phase II (SII) and slopes of phase III (SIII) of the capnogram. | 36 weeks PMA or until the end of supplemental oxygen dependancy assessed up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| several definitions of BPD |  | 36 weeks PMA | 
| duration of respiratory support |  | participants will be followed for the duration of hospital stay, an expected average of 12 weeks | 
| death |  | 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 | 
| necrotizing enterocolitis (NEC) |  | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchopulmonary dysplasia, preterm infant