Preterm Lung Function and Exercise Response Measured by OEP

• Conditions: Premature Birth

• 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.

Study Timeline

• Study Start: 2019-09-02
• Study First Submitted: 2019-10-01
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-20
• Last Update Submitted: 2020-01-20
• Study First Posted: 2020-01-27
• Last Update Posted: 2020-01-27
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01

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

Primary Outcome Measures

Name	Time	Method
Change in end-expiratory lung volume with exercise	Pre + post exercise (10minutes)	Change in end-expiratory lung volume measured in litres with exercise measured using optoelectronic plethysmography

Secondary Outcome Measures

Name	Time	Method
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%)
Change in tidal volume with exercise	During exercise (10 minutes)	Change in tidal volume with exercise measured in litres using optoelectronic plethysmography
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 plethysmography	Baseline	Baseline lung volume (in litres) measured using body plethysmography
FeNO	Baseline	Baseline FeNO (fraction of exhaled nitric oxide)
Exercise induced bronchoconstriction	10 minutes post exercise	% change in FEV1
Baseline activity levels	1 week period	Baseline activity levels measured using Actigraph monitor
Change in minute ventilation with exercise	During exercise (10 minutes)	Change in minute ventilation (measured in litres/minute) with exercise measured using optoelectronic plethysmography.

Trial Locations

Locations (1)

Royal Victoria Infirmary; 🇬🇧 Newcastle, Tyne And Wear, United Kingdom