Preterm Lung Function and Exercise Response Measured by OEP

NCT ID: NCT04239287

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-02
• Study Completion Date: 2021-09-01

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.

Conditions

Premature Birth

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Preterm

Children age 8-16 years born at \<32 weeks gestation.

Lung function + exercise tests

Intervention Type: DIAGNOSTIC_TEST

Lung function + exercise tests

Control

Children age 8-16 years born at \>37 weeks gestation

Lung function + exercise tests

Intervention Type: DIAGNOSTIC_TEST

Lung function + exercise tests

Interventions

Lung function + exercise tests

Lung function + exercise tests

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northumbria University

OTHER

Sponsor Role: collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher J O'Brien, MBBS

Role: PRINCIPAL_INVESTIGATOR

Newcastle upon Tyne Hospitals NHS Foundation Trust

Locations

Royal Victoria Infirmary

Newcastle, Tyne and Wear, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Rebecca J Naples, BMBCh

Role: CONTACT

rebecca.naples@nuth.nhs.uk

01912336161 ext. 39898

Facility Contacts

Rebecca J Naples, BMBCh

Role: primary

rebecca.naples@nuth.nhs.uk

01912336161 ext. 39898

Other Identifiers

09040

Identifier Type: -

Identifier Source: org_study_id