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Effect of Automated Oxygen Control on Early-childhood Lung Mechanics
Sponsor: King's College Hospital NHS Trust
Summary
Preterm infants are at higher risk of long-term respiratory problems and abnormal lung function in childhood. Respiratory support including mechanical ventilation, that is the use of a machine to move air into and out of the lungs, and oxygen treatment may further increase the risk of complications. In a randomised controlled trial, closed-loop automated oxygen control (CLAC) was associated with reductions in the duration of mechanical ventilation and oxygen treatment and may, therefore, help reduce long-term respiratory morbidity. The effect of CLAC systems on lung function has not been explored to date. This prospective observational study aims to explore the effect of automated oxygen control during the neonatal period on lung mechanics in children who were born at less than 34 weeks of gestation and required mechanical ventilation. The study will take place at King's College Hospital (KCH) children's outpatient department. Parents of children that participated in the randomised trial of automated versus manual oxygen control will be approached, informed and if appropriate consented to join the study. The study will measure outcomes including lung mechanics and parent-reported respiratory morbidity (breathing difficulties, respiratory infections, hospital admissions after discharge from neonatal care). Results will be compared between the two groups. Lung mechanics will be assessed using a technique called forced oscillation. This is a technique which involves the patient breathing through a face mask (if less than two years of age) or a mouthpiece filter (if older than two years). It is a non-invasive technique that measures lung function by superimposing gentle air pressure waves onto the patient's spontaneous breathing.An average of three measurements each one lasting up to 20 seconds will be performed. Parents will be asked to fill in a questionnaire regarding the health of their child after discharge from the neonatal unit. The study's duration will be 12 months.
Official title: Assessment of Early-childhood Lung Mechanics of Preterm-born Ventilated Infants That Received Automated or Manual Oxygen Control: a Single-centre Prospective Observational Study
Key Details
Gender
All
Age Range
1 Year - 5 Years
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2026-10-12
Completion Date
2027-10-12
Last Updated
2026-10-14
Healthy Volunteers
No
Interventions
Forced oscillometry technique
Patients will be assessed in a seated position with a nose clip in place and the investigator will support their cheeks and lower jaw. Children who cannot tolerate the nose clip will have their nose held by their accompanying parent/guardian. The participants will be breathing through a standard mouthpiece filter. Each FOT will be performed for 20 seconds. Testing will be repeated until a minimum of three tests is obtained with coherence of variance (CoV) equal or less than 15% at R5. The mean results of at least two adequate measurements will be used for analysis. For infants less than two years of age the TremoFlo N-100 Airwave Oscillometry System (Thorasys Thoracic Medical Systems Inc. Montreal, Quebec, Canada) will be used. The infants will be placed in supine position and will be breathing via a cushioned face mask covering the nose and mouth and a filter (Humid-Vent Filter Small, Teleflex Medical, Ireland). Measurements will be performed at the same frequencies.
Locations (1)
King's College Hospital NHS Foundation Trust
London, United Kingdom