Bronchopulmonary DysplasiaBPD-2014NCT02083562
Biomarkers and Volumetric Capnography in BPD
An observational study of Bronchopulmonary Dysplasia, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 5 to 9 days
- Conditions the study is for
- Bronchopulmonary Dysplasia
- How many people
- 210 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Nov 2013to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 days
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants born below 32 weeks PMA and admitted to the neonatal intensive care units in Basel and Berne, Switzerland.
Who may be able to join
- parental consent, born below 32 weeks PMA
Who cannot join
- No parental consent, major life-threatening anomalies (cardiac defects, primary pulmonary malformations etc.)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Department of Neonatology, University Children's Hospital Basel
Basel, 4031
Department of Neonatology, Inselpital Berne
Bern, 3010
About this study
Official title: 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).
Read the 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
- Keywords
- Bronchopulmonary dysplasia, preterm infant
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
association of plasma biomarker levels (pro-endothelin-1 precursor and other markers of respiratory distress) with the duration of supplemental oxygen dependancy in infancy
Measured: 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
Capnographic indices include expired carbon dioxide volume per breath, slopes of phase II (SII) and slopes of phase III (SIII) of the capnogram.
Measured: 36 weeks PMA or until the end of supplemental oxygen dependancy assessed up to 12 months
Secondary outcomes (8)
several definitions of BPD
Measured: 36 weeks PMA
duration of respiratory support
Measured: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
death
Measured: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
sepsis
Measured: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
necrotizing enterocolitis (NEC)
Measured: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
retinopathy of prematurity (ROP)
Measured: until completion of retinal vascularization or up to 6 months, whichever came first
intraventricular hemorrhage (IVH)
Measured: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
patent ductus arteriosus
Measured: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
- Investigators
- Roland P Neumann, MD, Principal investigator, Department of Neonatology, University Children's Hospital Basel, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083562
- Sponsor's protocol ID
- BPD-2014_UKBB
- Acronym
- BPD-2014
- Status last verified
- Sep 2018
- First submitted
- 25 Feb 2014
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 34687691
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Biomarkers for the Prediction of Bronchopulmonary Dysplasia and Volumetric Capnography for Severity Assessment of Lung Disease in Preterm Infants
- ClinicalTrials.gov ID
- NCT02083562
- Acronym / sponsor ID
- BPD-2014 / BPD-2014_UKBB
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Bronchopulmonary dysplasia, preterm infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- Nov 2013
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 9 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants born below 32 weeks PMA and admitted to the neonatal intensive care units in Basel and Berne, Switzerland.
Key inclusion criteria (1 listed)
- parental consent, born below 32 weeks PMA
Key exclusion criteria (1 listed)
- No parental consent, major life-threatening anomalies (cardiac defects, primary pulmonary malformations etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Derived from this study: PubMed 34687691Neumann 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland P Neumann, MD principal investigator
Department of Neonatology, University Children's Hospital Basel, Basel, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Assessment at 36 weeks PMA or until the end of supplemental oxygen dependancy assessed up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02083562, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.