Premature BirthNCT04239287
Preterm Lung Function and Exercise Response Measured by OEP
An observational study of Premature Birth, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Lung function + exercise tests
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Sep 2019to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Age 8-16 years
- Born at <32 weeks gestation (preterm) or >37 weeks gestation (controls)
- Parental consent obtained
Who cannot join
- Unable to comply with test procedure
- Respiratory illness within last 2 weeks
- Cardiac disease (excludes ligated PDA)
- Neuromuscular disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Victoria Infirmary
Newcastle, Tyne and Wear, NE1 4LP
Rebecca J Naples, BMBCh, 01912336161 ext. 39898, rebecca.naples@nuth.nhs.uk
Christopher J O'Brien, MBBS
About this study
Official title: Lung Function and Exercise Response Measured by Optoelectronic Plethysmography in School-aged Children Born Preterm
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.
Read the 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.
- Conditions
- Premature Birth
- Being tested
- Lung function + exercise tests
- Keywords
- Lung function, Exercise
- Medical subject headings
- Premature Birth, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung function + exercise testsDiagnostic test
Lung function + exercise tests
| Study group | Role | What they receive |
|---|---|---|
| Preterm | Children age 8-16 years born at <32 weeks gestation. Receives: Diagnostic Test: Lung function + exercise tests | |
| Control | Children age 8-16 years born at >37 weeks gestation Receives: Diagnostic Test: Lung function + exercise tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in end-expiratory lung volume with exercise
Change in end-expiratory lung volume measured in litres with exercise measured using optoelectronic plethysmography
Measured: Pre + post exercise (10minutes)
Secondary outcomes (10)
Change in tidal volume with exercise
Change in tidal volume with exercise measured in litres using optoelectronic plethysmography
Measured: During exercise (10 minutes)
Change in minute ventilation with exercise
Change in minute ventilation (measured in litres/minute) with exercise measured using optoelectronic plethysmography.
Measured: During exercise (10 minutes)
Baseline forced expiratory volume in 1 second (FEV1)
Baseline forced expiratory volume (in litres) in 1 second measured by spirometry (FEV1)
Measured: Baseline
Forced vital capacity (FVC)
Baseline forced vital capacity measured in litres (FVC)
Measured: Baseline
Forced mid-expiratory flow (FEF25-75%)
Mean forced expiratory flow between 25% and 75% of FVC measured in litres/second (FEF25-75%)
Measured: Baseline
Transfer factor for carbon monoxide (TLCO)
Transfer factor for carbon monoxide (measured in millimoles per minute per kilopascal) using single breath test
Measured: Baseline
Body plethysmography
Baseline lung volume (in litres) measured using body plethysmography
Measured: Baseline
FeNO
Baseline FeNO (fraction of exhaled nitric oxide)
Measured: Baseline
Exercise induced bronchoconstriction
% change in FEV1
Measured: 10 minutes post exercise
Baseline activity levels
Baseline activity levels measured using Actigraph monitor
Measured: 1 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start2 Sep 2019
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Northumbria University
- Responsible party
- Sponsor
- Investigators
- Christopher J O'Brien, MBBS, Principal investigator, Newcastle upon Tyne Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239287
- Sponsor's protocol ID
- 09040
- Status last verified
- Jan 2020
- First submitted
- 1 Oct 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Function and Exercise Response Measured by Optoelectronic Plethysmography in School-aged Children Born Preterm
- ClinicalTrials.gov ID
- NCT04239287
- Acronym / sponsor ID
- 09040
- Conditions
- Premature Birth
- Keywords
- Lung function, Exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Northumbria University
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm | – | Diagnostic Test: Lung function + exercise testsChildren age 8-16 years born at <32 weeks gestation. |
| Control | – | Diagnostic Test: Lung function + exercise testsChildren age 8-16 years born at >37 weeks gestation |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Age 8-16 years
- Born at <32 weeks gestation (preterm) or >37 weeks gestation (controls)
- Parental consent obtained
Key exclusion criteria (4 listed)
- Unable to comply with test procedure
- Respiratory illness within last 2 weeks
- Cardiac disease (excludes ligated PDA)
- Neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung function + exercise testsLung function + exercise tests | Diagnostic test | Control, Preterm |
Primary outcome
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
10 secondary outcomes
Change in tidal volume with exercise
Time frame: During exercise (10 minutes)
Change in minute ventilation with exercise
Time frame: During exercise (10 minutes)
Baseline forced expiratory volume in 1 second (FEV1)
Time frame: Baseline
Forced vital capacity (FVC)
Time frame: Baseline
Forced mid-expiratory flow (FEF25-75%)
Time frame: Baseline
Transfer factor for carbon monoxide (TLCO)
Time frame: Baseline
Body plethysmography
Time frame: Baseline
FeNO
Time frame: Baseline
Exercise induced bronchoconstriction
Time frame: 10 minutes post exercise
Baseline activity levels
Time frame: 1 week period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Premature Birth
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J O'Brien, MBBS principal investigator
Newcastle upon Tyne Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca J Naples, BMBCh (01912336161 ext. 39898, rebecca.naples@nuth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in end-expiratory lung volume with exercise (time frame: Pre + post exercise (10minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.