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Completed

NCT Number: NCT02083562

Biomarkers and Volumetric Capnography in BPD

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).

Completed

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

5 day–9 day

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • parental consent, born below 32 weeks PMA

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern

Registry information

Official study title

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

Acronym: BPD-2014

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Mar 11, 2014
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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