An observational study in Prematurity, Respiratory Distress Neonatal and Oxygen Delivery, sponsored by King's College Hospital NHS Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by King's College Hospital NHS Trust · Observational
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.
Eligible infants will be identified from the recruitment log of the study 'Optimising ventilation in preterms with closed-loop oxygen control' (IRAS: 297749). These children were born between September 2021 and February 2025. Parents of all survivors will be approached via a phone call and/ or email by the investigators. The parents will be provided with an information sheet about the study via email. The researchers will answer questions over the phone/ via email and face-to-face during the appointment. Written informed consent will be obtained.
The children will be asked to attend the outpatient department at King's College Hospital when clinically well and without respiratory tract infections in the previous four weeks.
Demographic information will be obtained from the children's medical records including gestational age, birth weight, antenatal steroids, administration of surfactant, duration of mechanical ventilation and oxygen treatment, postnatal steroids, diagnosis of bronchopulmonary dysplasia, that is a chronic lung disease, and need for home oxygen.
Body weight and height at the time of testing will be measured and recorded. The Thorasys Tremoflo-C100 Airwave Oscillometry System TM (Thorasys, Montreal, QC, Canada) will be used with Thorasys software for children at or above two years of age. The device will measure lung resistance and reactance (compliance) at specific frequencies.
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. Forced oscillometry testing will be performed for 20 seconds. Measurements will be repeated until a minimum of three valid tests is obtained. 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 as the older children.
Parents will be invited to fill in a questionnaire related to their child's health following discharge from the neonatal unit. This will include questions about duration of home oxygen treatment, frequency of breathing difficulties, any respiratory infections requiring antibiotics, hospital admissions and their reasons, and presence of smokers in the household.
All measurements will be completed during a single clinic visit on the same day and no follow up will be required.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 60 is below the median of 112 across 777 observational studies indexed under Premature Birth.
Browse Premature Birth studies →King's College Hospital NHS Trust is the lead sponsor of 165 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Preterm-born children requiring mechanical ventilation at birth who participated in a randomised controlled trial of automated versus manual oxygen control.
Exclusion Criteria:
Preterm-born children \<34 weeks gestation that participated in a randomised controlled trial of automated versus manual oxygen control in the early neonatal period will be included in the study. Lung mechanics will be measured via forced oscillometry technique at follow up.
Other: 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.
The increase in respiratory resistance (R) in centimeters water per liter per second of participants who received automated oxygen control in the neonatal period compared to those who received manual oxygen control.
Time frame: From enrollment to the end of monitoring at one hour.
The reduction in respiratory reactance (X) in centimeters water per liter per second of participants who received automated oxygen control in the neonatal period compared to those who received manual oxygen control.
Time frame: From enrollment to the end of monitoring at one hour.
To evaluate differences in the frequency of episodes of breathing difficulties (number of episodes per month) after discharge from neonatal care with the use of parent-questionnaires.
Time frame: From enrolment to the end of monitoring at one hour.
To evaluate differences in the absolute number of courses of antibiotics given for respiratory infections after discharge from neonatal care with the use of parent-questionnaires.
Time frame: From enrollment to the end of monitoring at one hour.
To evaluate differences in the absolute number of hospital readmissions after discharge from neonatal care with the use of parent-questionnaires.
Time frame: From enrollment to the end of monitoring at one hour.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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King's College Hospital NHS Trust