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Preterm Lung Function and Exercise Response Measured by OEP

Conditions
Premature Birth
Interventions
Diagnostic Test: Lung function + exercise tests
Registration Number
NCT04239287
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
PretermLung function + exercise testsChildren age 8-16 years born at \<32 weeks gestation.
ControlLung function + exercise testsChildren age 8-16 years born at \>37 weeks gestation
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Baseline activity levels1 week period

Baseline activity levels measured using Actigraph monitor

Change in tidal volume with exerciseDuring exercise (10 minutes)

Change in tidal volume with exercise measured in litres using optoelectronic plethysmography

Change in minute ventilation with exerciseDuring exercise (10 minutes)

Change in minute ventilation (measured in litres/minute) with exercise measured using optoelectronic plethysmography.

Forced vital capacity (FVC)Baseline

Baseline forced vital capacity measured in litres (FVC)

Forced mid-expiratory flow (FEF25-75%)Baseline

Mean forced expiratory flow between 25% and 75% of FVC measured in litres/second (FEF25-75%)

Baseline forced expiratory volume in 1 second (FEV1)Baseline

Baseline forced expiratory volume (in litres) in 1 second measured by spirometry (FEV1)

Transfer factor for carbon monoxide (TLCO)Baseline

Transfer factor for carbon monoxide (measured in millimoles per minute per kilopascal) using single breath test

Body plethysmographyBaseline

Baseline lung volume (in litres) measured using body plethysmography

FeNOBaseline

Baseline FeNO (fraction of exhaled nitric oxide)

Exercise induced bronchoconstriction10 minutes post exercise

% change in FEV1

Trial Locations

Locations (1)

Royal Victoria Infirmary

🇬🇧

Newcastle, Tyne And Wear, United Kingdom

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