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Clinical Trials/NCT04239287
NCT04239287
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Lung Function and Exercise Response Measured by Optoelectronic Plethysmography in School-aged Children Born Preterm

Newcastle-upon-Tyne Hospitals NHS Trust1 site in 1 country60 target enrollmentSeptember 2, 2019
ConditionsPremature Birth

Overview

Phase
N/A
Intervention
Not specified
Conditions
Premature Birth
Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Enrollment
60
Locations
1
Primary Endpoint
Change in end-expiratory lung volume with exercise
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2, 2019
End Date
September 1, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Forced vital capacity (FVC)(Baseline)
  • Forced mid-expiratory flow (FEF25-75%)(Baseline)
  • Change in tidal volume with exercise(During exercise (10 minutes))
  • Change in minute ventilation with exercise(During exercise (10 minutes))
  • Baseline forced expiratory volume in 1 second (FEV1)(Baseline)
  • Transfer factor for carbon monoxide (TLCO)(Baseline)
  • Body plethysmography(Baseline)
  • FeNO(Baseline)
  • Exercise induced bronchoconstriction(10 minutes post exercise)
  • Baseline activity levels(1 week period)

Study Sites (1)

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