Preterm Lung Function and Exercise Response Measured by OEP

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04239287
• Other study ID #: 09040
• Status: Recruiting
• Start date: September 2, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: January 2020
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: Rebecca J Naples, BMBCh
• Phone: 01912336161
• Email: rebecca.naples[@]nuth.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 breathing patterns.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Diagnostic Test:
• Lung function + exercise tests
Lung function + exercise tests

Locations

Country	Name	City	State
United Kingdom	Royal Victoria Infirmary	Newcastle	Tyne And Wear

Sponsors (2)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust	Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in end-expiratory lung volume with exercise	Change in end-expiratory lung volume measured in litres with exercise measured using optoelectronic plethysmography	Pre + post exercise (10minutes)
Secondary	Change in tidal volume with exercise	Change in tidal volume with exercise measured in litres using optoelectronic plethysmography	During exercise (10 minutes)
Secondary	Change in minute ventilation with exercise	Change in minute ventilation (measured in litres/minute) with exercise measured using optoelectronic plethysmography.	During exercise (10 minutes)
Secondary	Baseline forced expiratory volume in 1 second (FEV1)	Baseline forced expiratory volume (in litres) in 1 second measured by spirometry (FEV1)	Baseline
Secondary	Forced vital capacity (FVC)	Baseline forced vital capacity measured in litres (FVC)	Baseline
Secondary	Forced mid-expiratory flow (FEF25-75%)	Mean forced expiratory flow between 25% and 75% of FVC measured in litres/second (FEF25-75%)	Baseline
Secondary	Transfer factor for carbon monoxide (TLCO)	Transfer factor for carbon monoxide (measured in millimoles per minute per kilopascal) using single breath test	Baseline
Secondary	Body plethysmography	Baseline lung volume (in litres) measured using body plethysmography	Baseline
Secondary	FeNO	Baseline FeNO (fraction of exhaled nitric oxide)	Baseline
Secondary	Exercise induced bronchoconstriction	% change in FEV1	10 minutes post exercise
Secondary	Baseline activity levels	Baseline activity levels measured using Actigraph monitor	1 week period