Preterm Lung Function and Exercise Response Measured by OEP

NCT04239287 | Unknown

• 1 other identifier: 09040
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

Lung function; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in tidal volume with exercise

  During exercise (10 minutes)

• Change in minute ventilation with exercise

  During exercise (10 minutes)

• Baseline forced expiratory volume in 1 second (FEV1)

  Baseline

• Forced vital capacity (FVC)

  Baseline

• Forced mid-expiratory flow (FEF25-75%)

  Baseline

Study Arms (2)

Preterm

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

Diagnostic Test: Lung function + exercise tests

Control

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

Diagnostic Test: Lung function + exercise tests

Interventions

Lung function + exercise tests DIAGNOSTIC_TEST

Lung function + exercise tests

Control; Preterm

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Age 8-16 years
• Born at \<32 weeks gestation (preterm) or \>37 weeks gestation (controls)
• Parental consent obtained

You may not qualify if:

• Unable to comply with test procedure
• Respiratory illness within last 2 weeks
• Cardiac disease (excludes ligated PDA)
• Neuromuscular disease

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead
• Northumbria University: collaborator

Study Sites (1)

Royal Victoria Infirmary

Newcastle, Tyne and Wear, NE1 4LP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Premature Birth; Motor Activity

Interventions

Respiration; Exercise Test

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Christopher J O'Brien, MBBS

  Newcastle upon Tyne Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca J Naples, BMBCh

CONTACT

01912336161; rebecca.naples@nuth.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: January 27, 2020
• Study Start: September 2, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

GB (1)