Clinical trial NCT02083562: Biomarkers and Volumetric Capnography in BPD
Official title: Plasma Biomarkers for the Prediction of Bronchopulmonary Dysplasia and Volumetric Capnography for Severity Assessment of Lung Disease in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary dysplasia, preterm infant
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2014-03-11
Enrollment: 210
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants born below 32 weeks PMA and admitted to the neonatal intensive care units in Basel and Berne, Switzerland.

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* parental consent, born below 32 weeks PMA

Exclusion Criteria:

* No parental consent, major life-threatening anomalies (cardiac defects, primary pulmonary malformations etc.)

Primary outcomes:
measure: association of plasma biomarker levels (pro-endothelin-1 precursor and other markers of respiratory distress) with the duration of supplemental oxygen dependancy in infancy
timeFrame: Assessment at 36 weeks PMA or until the end of supplemental oxygen dependancy assessed up to 12 months
measure: association of capnographic indices with the duration of supplemental oxygen dependancy
timeFrame: 36 weeks PMA or until the end of supplemental oxygen dependancy assessed up to 12 months
Secondary outcomes:
measure: several definitions of BPD
timeFrame: 36 weeks PMA
measure: duration of respiratory support
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
measure: death
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
measure: sepsis
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
measure: necrotizing enterocolitis (NEC)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
measure: retinopathy of prematurity (ROP)
timeFrame: until completion of retinal vascularization or up to 6 months, whichever came first
measure: intraventricular hemorrhage (IVH)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
measure: patent ductus arteriosus
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Neonatology, University Children's Hospital Basel
city: Berne
country: Switzerland
facility: Department of Neonatology, Inselpital Berne
Study officials:
affiliation: Department of Neonatology, University Children's Hospital Basel, Basel, Switzerland
name: Roland P Neumann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neumann RP, Gerull R, Zannin E, Fouzas S, Schulzke SM. Volumetric Capnography at 36 Weeks Postmenstrual Age and Bronchopulmonary Dysplasia in Very Preterm Infants. J Pediatr. 2022 Feb;241:97-102.e2. doi: 10.1016/j.jpeds.2021.10.019. Epub 2021 Oct 24.