Preterm Lung Function and Exercise Response Measured by OEP

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.

Study Overview

• Status: Unknown
• Conditions: Premature Birth
• Intervention / Treatment: Diagnostic test: Lung function + exercise tests

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Rebecca J Naples, BMBCh; Phone Number: 39898 01912336161; Email: rebecca.naples@nuth.nhs.uk

Study Locations

• United Kingdom
  • Tyne And Wear
    • Newcastle, Tyne And Wear, United Kingdom, NE1 4LP
      • Recruiting
      • Royal Victoria Infirmary
      • Contact: Rebecca J Naples, BMBCh; Phone Number: 39898 01912336161; Email: rebecca.naples@nuth.nhs.uk
      • Principal Investigator: Christopher J O'Brien, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preterm; Children age 8-16 years born at <32 weeks gestation.	Diagnostic test: Lung function + exercise tests; Lung function + exercise tests
Control; Children age 8-16 years born at >37 weeks gestation	Diagnostic test: Lung function + exercise tests; Lung function + exercise tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Collaborators: Northumbria University
• Investigators: Principal Investigator: Christopher J O'Brien, MBBS, Newcastle Upon Tyne Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Lung function
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 09040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No