Biomarkers and Volumetric Capnography in BPD

Bronchopulmonary Dysplasia Clinical Trial

— BPD-2014  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083562
• Other study ID #: BPD-2014_UKBB
• Status: Completed
• Start date: November 2013
• Est. completion date: June 2018

Study information

• Verified date: September 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 9 Days

Eligibility

Inclusion Criteria:

• parental consent, born below 32 weeks PMA

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Locations

Country	Name	City	State
Switzerland	Department of Neonatology, University Children's Hospital Basel	Basel
Switzerland	Department of Neonatology, Inselpital Berne	Berne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	several definitions of BPD		36 weeks PMA
Secondary	duration of respiratory support		participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Secondary	death		participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Secondary	sepsis		participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Secondary	necrotizing enterocolitis (NEC)		participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Secondary	retinopathy of prematurity (ROP)		until completion of retinal vascularization or up to 6 months, whichever came first
Secondary	intraventricular hemorrhage (IVH)		participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Secondary	patent ductus arteriosus		participants will be followed for the duration of hospital stay, an expected average of 12 weeks