Clinical trial NCT04239287: Preterm Lung Function and Exercise Response Measured by OEP
Official title: Lung Function and Exercise Response Measured by Optoelectronic Plethysmography in School-aged Children Born Preterm
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Birth
Keywords: Lung function
Exercise
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Northumbria University
First posted: 2020-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm participants will be aged 8-16 years, and previously admitted to the neonatal unit at the Royal Victoria Infirmary, Newcastle upon Tyne.

Controls will be healthy volunteers.

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.

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

Primary outcomes:
measure: Change in end-expiratory lung volume with exercise
timeFrame: Pre + post exercise (10minutes)
Secondary outcomes:
measure: Change in tidal volume with exercise
timeFrame: During exercise (10 minutes)
measure: Change in minute ventilation with exercise
timeFrame: During exercise (10 minutes)
measure: Baseline forced expiratory volume in 1 second (FEV1)
timeFrame: Baseline
measure: Forced vital capacity (FVC)
timeFrame: Baseline
measure: Forced mid-expiratory flow (FEF25-75%)
timeFrame: Baseline
measure: Transfer factor for carbon monoxide (TLCO)
timeFrame: Baseline
measure: Body plethysmography
timeFrame: Baseline
measure: FeNO
timeFrame: Baseline
measure: Exercise induced bronchoconstriction
timeFrame: 10 minutes post exercise
measure: Baseline activity levels
timeFrame: 1 week period
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
state: Tyne And Wear
Study officials:
affiliation: Newcastle upon Tyne Hospitals NHS Foundation Trust
name: Christopher J O'Brien, MBBS
role: PRINCIPAL_INVESTIGATOR
References: