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Preterm Lung Function and Exercise Response Measured by OEP

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ClinicalTrials.gov Identifier: NCT04239287
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Northumbria University
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Brief Summary:
This study will explore lung function and respiratory health in school-aged children who were born prematurely at <32 weeks gestation. It will involve full lung function assessment, a questionnaire and discussion about respiratory health, and an exercise test using optoelectronic plethysmography (OEP) to measure breathing patterns.

Condition or disease Intervention/treatment
Premature Birth Diagnostic Test: Lung function + exercise tests

Detailed Description:

Preterm are born during a critical stage of lung development, and can have abnormalities in lung function that persist with age. Previous studies have shown that children with BPD have reduced lung function and limited exercise capacity. These studies have used conventional lung function testing which requires a tight fitting mask. This is uncomfortable, may alter normal breathing patterns and cannot measure changes in total lung volume.

Optoelectronic plethysmography (OEP) indirectly measures lung volumes and breathing patterns using cameras to track the position of marker stickers on the chest, back and abdomen. It is comfortable, does not require a mask and allows us to track changes in total lung volume.

This study will use standard lung function testing and OEP to measure lung function and breathing patterns at rest and during exercise in school-aged children born prematurely, compared to healthy children born at full term. All participants will complete standard lung function tests, a questionnaire and structured interview to qualitatively assess respiratory health, and an exercise test using OEP to assess how breathing changes with exercise.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Lung Function and Exercise Response Measured by Optoelectronic Plethysmography in School-aged Children Born Preterm
Actual Study Start Date : September 2, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Preterm
Children age 8-16 years born at <32 weeks gestation.
Diagnostic Test: Lung function + exercise tests
Lung function + exercise tests

Control
Children age 8-16 years born at >37 weeks gestation
Diagnostic Test: Lung function + exercise tests
Lung function + exercise tests




Primary Outcome Measures :
  1. Change in end-expiratory lung volume with exercise [ Time Frame: Pre + post exercise (10minutes) ]
    Change in end-expiratory lung volume measured in litres with exercise measured using optoelectronic plethysmography


Secondary Outcome Measures :
  1. Change in tidal volume with exercise [ Time Frame: During exercise (10 minutes) ]
    Change in tidal volume with exercise measured in litres using optoelectronic plethysmography

  2. Change in minute ventilation with exercise [ Time Frame: During exercise (10 minutes) ]
    Change in minute ventilation (measured in litres/minute) with exercise measured using optoelectronic plethysmography.

  3. Baseline forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline ]
    Baseline forced expiratory volume (in litres) in 1 second measured by spirometry (FEV1)

  4. Forced vital capacity (FVC) [ Time Frame: Baseline ]
    Baseline forced vital capacity measured in litres (FVC)

  5. Forced mid-expiratory flow (FEF25-75%) [ Time Frame: Baseline ]
    Mean forced expiratory flow between 25% and 75% of FVC measured in litres/second (FEF25-75%)

  6. Transfer factor for carbon monoxide (TLCO) [ Time Frame: Baseline ]
    Transfer factor for carbon monoxide (measured in millimoles per minute per kilopascal) using single breath test

  7. Body plethysmography [ Time Frame: Baseline ]
    Baseline lung volume (in litres) measured using body plethysmography

  8. FeNO [ Time Frame: Baseline ]
    Baseline FeNO (fraction of exhaled nitric oxide)

  9. Exercise induced bronchoconstriction [ Time Frame: 10 minutes post exercise ]
    % change in FEV1

  10. Baseline activity levels [ Time Frame: 1 week period ]
    Baseline activity levels measured using Actigraph monitor



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Preterm participants will be aged 8-16 years, and previously admitted to the neonatal unit at the Royal Victoria Infirmary, Newcastle upon Tyne.

Controls will be healthy volunteers.

Criteria

Inclusion Criteria:

  • Age 8-16 years
  • Born at <32 weeks gestation (preterm) or >37 weeks gestation (controls)
  • Parental consent obtained

Exclusion Criteria:

  • Unable to comply with test procedure
  • Respiratory illness within last 2 weeks
  • Cardiac disease (excludes ligated PDA)
  • Neuromuscular disease

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): NCT04239287


Contacts
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Contact: Rebecca J Naples, BMBCh 01912336161 ext 39898 rebecca.naples@nuth.nhs.uk

Locations
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United Kingdom
Royal Victoria Infirmary Recruiting
Newcastle, Tyne And Wear, United Kingdom, NE1 4LP
Contact: Rebecca J Naples, BMBCh    01912336161 ext 39898    rebecca.naples@nuth.nhs.uk   
Principal Investigator: Christopher J O'Brien, MBBS         
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Northumbria University
Investigators
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Principal Investigator: Christopher J O'Brien, MBBS Newcastle upon Tyne Hospitals NHS Foundation Trust

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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04239287    
Other Study ID Numbers: 09040
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Lung function
Exercise
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications