Biomarkers and Volumetric Capnography in BPD

NCT ID: NCT02083562

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2018-06-30

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.

Conditions

Bronchopulmonary Dysplasia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.)

• Minimum Eligible Age: 5 Days
• Maximum Eligible Age: 9 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland P Neumann, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neonatology, University Children's Hospital Basel, Basel, Switzerland

Locations

Department of Neonatology, University Children's Hospital Basel

Basel, , Switzerland

Department of Neonatology, Inselpital Berne

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 34687691 (View on PubMed)

Other Identifiers

BPD-2014_UKBB

Identifier Type: -

Identifier Source: org_study_id