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Biomarkers and Volumetric Capnography in BPD (BPD-2014)

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ClinicalTrials.gov Identifier: NCT02083562
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
University Hospital, Basel, 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).


Condition or disease
Bronchopulmonary Dysplasia

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.

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Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plasma Biomarkers for the Prediction of Bronchopulmonary Dysplasia and Volumetric Capnography for Severity Assessment of Lung Disease in Preterm Infants
Study Start Date : November 2013
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]
  2. 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.


Secondary Outcome Measures :
  1. several definitions of BPD [ Time Frame: 36 weeks PMA ]
  2. duration of respiratory support [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  3. death [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  4. sepsis [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  5. necrotizing enterocolitis (NEC) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  6. retinopathy of prematurity (ROP) [ Time Frame: until completion of retinal vascularization or up to 6 months, whichever came first ]
  7. intraventricular hemorrhage (IVH) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  8. patent ductus arteriosus [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]

Biospecimen Retention:   Samples Without DNA
Plasma


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Ages Eligible for Study:   up to 9 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083562


Locations
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Switzerland
Department of Neonatology, University Children's Hospital Basel
Basel, Switzerland, 4031
Department of Neonatology, Inselpital Berne
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Roland P Neumann, MD Department of Neonatology, University Children's Hospital Basel, Basel, Switzerland

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02083562     History of Changes
Other Study ID Numbers: BPD-2014_UKBB
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Basel, Switzerland:
Bronchopulmonary dysplasia, preterm infant
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases