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).
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.
Study Type
OBSERVATIONAL
Enrollment
210
Department of Neonatology, University Children's Hospital Basel
Basel, Switzerland
Department of Neonatology, Inselpital Berne
Bern, Switzerland
association of plasma biomarker levels (pro-endothelin-1 precursor and other markers of respiratory distress) with the duration of supplemental oxygen dependancy in infancy
Time frame: 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.
Time frame: 36 weeks PMA or until the end of supplemental oxygen dependancy assessed up to 12 months
several definitions of BPD
Time frame: 36 weeks PMA
duration of respiratory support
Time frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
death
Time frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
sepsis
Time frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
necrotizing enterocolitis (NEC)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
retinopathy of prematurity (ROP)
Time frame: until completion of retinal vascularization or up to 6 months, whichever came first
intraventricular hemorrhage (IVH)
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Time frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
patent ductus arteriosus
Time frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks