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Preterm Lung Function and Exercise Response Measured by OEP

Lung Function and Exercise Response Measured by Optoelectronic Plethysmography in School-aged Children Born Preterm

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04239287
Enrollment
60
Registered
2020-01-27
Start date
2019-09-02
Completion date
2021-09-01
Last updated
2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

Lung function, Exercise

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.

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_TESTLung function + exercise tests

Lung function + exercise tests

Sponsors

Northumbria University
CollaboratorOTHER
Newcastle-upon-Tyne Hospitals NHS Trust
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in end-expiratory lung volume with exercisePre + post exercise (10minutes)Change in end-expiratory lung volume measured in litres with exercise measured using optoelectronic plethysmography

Secondary

MeasureTime frameDescription
Change in minute ventilation with exerciseDuring 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)BaselineBaseline forced expiratory volume (in litres) in 1 second measured by spirometry (FEV1)
Forced vital capacity (FVC)BaselineBaseline forced vital capacity measured in litres (FVC)
Forced mid-expiratory flow (FEF25-75%)BaselineMean forced expiratory flow between 25% and 75% of FVC measured in litres/second (FEF25-75%)
Change in tidal volume with exerciseDuring exercise (10 minutes)Change in tidal volume with exercise measured in litres using optoelectronic plethysmography
Body plethysmographyBaselineBaseline lung volume (in litres) measured using body plethysmography
FeNOBaselineBaseline FeNO (fraction of exhaled nitric oxide)
Exercise induced bronchoconstriction10 minutes post exercise% change in FEV1
Baseline activity levels1 week periodBaseline activity levels measured using Actigraph monitor
Transfer factor for carbon monoxide (TLCO)BaselineTransfer factor for carbon monoxide (measured in millimoles per minute per kilopascal) using single breath test

Countries

United Kingdom

Contacts

Primary ContactRebecca J Naples, BMBCh
rebecca.naples@nuth.nhs.uk01912336161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026