Clinical Trial: Biomarkers and Volumetric Capnography in BPD

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary:

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 Summary: 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.
Sponsor: University Hospital, Basel, Switzerland

Current Primary Outcome:

  • 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 [ Time Frame: 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.


Original Primary Outcome:

  • 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 [ Time Frame: 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 SII and SIII of the capnogram.


Current Secondary Outcome:

  • 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) [ 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 ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: February 25, 2014
Date Started: November 2013
Date Completion: July 2018
Last Updated: April 11, 2017
Last Verified: April 2017