Preterm Lung Function and Exercise Response Measured by OEP
Overview
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.
Full Title of Study: “Lung Function and Exercise Response Measured by Optoelectronic Plethysmography in School-aged Children Born Preterm”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Cross-Sectional
- Study Primary Completion Date: September 1, 2021
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.
Interventions
- Diagnostic Test: Lung function + exercise tests
- Lung function + exercise tests
Arms, Groups and Cohorts
- Preterm
- Children age 8-16 years born at <32 weeks gestation.
- Control
- Children age 8-16 years born at >37 weeks gestation
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- Change in tidal volume with exercise
- Time Frame: During exercise (10 minutes)
- Change in tidal volume with exercise measured in litres using optoelectronic plethysmography
- 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.
- Baseline forced expiratory volume in 1 second (FEV1)
- Time Frame: Baseline
- Baseline forced expiratory volume (in litres) in 1 second measured by spirometry (FEV1)
- Forced vital capacity (FVC)
- Time Frame: Baseline
- Baseline forced vital capacity measured in litres (FVC)
- 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%)
- 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
- Body plethysmography
- Time Frame: Baseline
- Baseline lung volume (in litres) measured using body plethysmography
- FeNO
- Time Frame: Baseline
- Baseline FeNO (fraction of exhaled nitric oxide)
- Exercise induced bronchoconstriction
- Time Frame: 10 minutes post exercise
- % change in FEV1
- Baseline activity levels
- Time Frame: 1 week period
- Baseline activity levels measured using Actigraph monitor
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 8 Years
Maximum Age: 16 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Collaborator
- Northumbria University
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Christopher J O’Brien, MBBS, Principal Investigator, Newcastle upon Tyne Hospitals NHS Foundation Trust
- Overall Contact(s)
- Rebecca J Naples, BMBCh, 01912336161, rebecca.naples@nuth.nhs.uk
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.