Biomarkers and Volumetric Capnography in BPD (BPD-2014)

September 10, 2018 updated by: University Hospital, Basel, Switzerland

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

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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Neonatology, University Children's Hospital Basel
      • Berne, Switzerland, 3010
        • Department of Neonatology, Inselpital Berne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 days to 1 week (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • parental consent, born below 32 weeks PMA

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
36 weeks PMA or until the end of supplemental oxygen dependancy assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
several definitions of BPD
Time Frame: 36 weeks PMA
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
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
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
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
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
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
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
participants will be followed for the duration of hospital stay, an expected average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Roland P Neumann, MD, Department of Neonatology, University Children's Hospital Basel, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

June 1, 2018

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (ESTIMATE)

March 11, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPD-2014_UKBB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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