PrematurityNCT07866820
Effect of Automated Oxygen Control on Early-childhood Lung Mechanics
An observational study of Prematurity and Respiratory Distress Neonatal, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Prematurity, Respiratory Distress Neonatal, Oxygen Delivery
- What is being tested?
- Forced oscillometry technique
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Oct 2026to 12 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Preterm-born children requiring mechanical ventilation at birth who participated in a randomised controlled trial of automated versus manual oxygen control.
Who may be able to join
- Preterm-born children <34 weeks gestation that participated in a randomised controlled trial of automated versus manual oxygen control in the early neonatal period and:
- survived to early childhood
- do not require continuous non-invasive ventilation
- do not have a tracheostomy.
Who cannot join
- Infants excluded from the previous randomised trial
- Infants who did not survive to early childhood
- Survivors in need of continuous non-invasive ventilation
- Survivors with a tracheostomy
- Non-English speakers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Ourania Kaltsogianni, MD (Res), 38494 ext. 38494, ourania.kaltsogianni@nhs.net
Anne, anne.greenough@kcl.ac.uk
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Prematurity, Respiratory Distress Neonatal, Oxygen Delivery
- Being tested
- Forced oscillometry technique
- Keywords
- automated oxygen control, preterm infant, lung function, function oscillometry
- Medical subject headings
- Premature Birth, Hyaline Membrane Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced oscillometry techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Preterm-born children at one to five years of age | 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. Receives: Other: Forced oscillometry technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of monitoring at one hour.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of monitoring at one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start12 Oct 2026 (estimated)
- Primary completion12 Oct 2027 (estimated)
- Study completion12 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866820
- Sponsor's protocol ID
- 368851
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skylogianni E, Douros K, Anthracopoulos MB, Fouzas S. The Forced Oscillation Technique in Paediatric Respiratory Practice. Paediatr Respir Rev. 2016 Mar;18:46-51. doi: 10.1016/j.prrv.2015.11.001. Epub 2015 Nov 10.
PubMed 26777151Gie A, Swanepoel R, van der Zalm MM, Goussard P. The use of forced oscillation technique in children with restrictive physiology. Breathe (Sheff). 2025 May 13;21(2):240106. doi: 10.1183/20734735.0106-2024. eCollection 2025 Apr.
PubMed 40365096Klinger AP, Travers CP, Martin A, Kuo HC, Alishlash AS, Harris WT, Carlo WA, Ambalavanan N. Non-invasive forced oscillometry to quantify respiratory mechanics in term neonates. Pediatr Res. 2020 Aug;88(2):293-299. doi: 10.1038/s41390-020-0751-7. Epub 2020 Jan 14.
PubMed 31935746Kaltsogianni O, Dassios T, Jenkinson A, Jeffreys E, Ikeda K, Sugino M, Greenough A. Closed-loop automated oxygen control in preterm ventilated infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2026 Apr 17;111(3):F243-F248. doi: 10.1136/archdischild-2025-329022.
PubMed 41218846
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07866820
- Acronym / sponsor ID
- 368851
- Conditions
- Prematurity, Respiratory Distress Neonatal, Oxygen Delivery
- Keywords
- automated oxygen control, preterm infant, lung function, function oscillometry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 12 Oct 2027 (estimated)
- Study completion
- 12 Oct 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm-born children at one to five years of age | – | Other: Forced oscillometry techniquePreterm-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. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm-born children requiring mechanical ventilation at birth who participated in a randomised controlled trial of automated versus manual oxygen control.
Key inclusion criteria (4 listed)
- Preterm-born children <34 weeks gestation that participated in a randomised controlled trial of automated versus manual oxygen control in the early neonatal period and:
- survived to early childhood
- do not require continuous non-invasive ventilation
- do not have a tracheostomy.
Key exclusion criteria (5 listed)
- Infants excluded from the previous randomised trial
- Infants who did not survive to early childhood
- Survivors in need of continuous non-invasive ventilation
- Survivors with a tracheostomy
- Non-English speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forced oscillometry techniquePatients 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. | Other | Preterm-born children at one to five years of age |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Results publication: PubMed 26777151Skylogianni E, Douros K, Anthracopoulos MB, Fouzas S. The Forced Oscillation Technique in Paediatric Respiratory Practice. Paediatr Respir Rev. 2016 Mar;18:46-51. doi: 10.1016/j.prrv.2015.11.001. Epub 2015 Nov 10.
- Results publication: PubMed 40365096Gie A, Swanepoel R, van der Zalm MM, Goussard P. The use of forced oscillation technique in children with restrictive physiology. Breathe (Sheff). 2025 May 13;21(2):240106. doi: 10.1183/20734735.0106-2024. eCollection 2025 Apr.
- Results publication: PubMed 31935746Klinger AP, Travers CP, Martin A, Kuo HC, Alishlash AS, Harris WT, Carlo WA, Ambalavanan N. Non-invasive forced oscillometry to quantify respiratory mechanics in term neonates. Pediatr Res. 2020 Aug;88(2):293-299. doi: 10.1038/s41390-020-0751-7. Epub 2020 Jan 14.
- Results publication: PubMed 41218846Kaltsogianni O, Dassios T, Jenkinson A, Jeffreys E, Ikeda K, Sugino M, Greenough A. Closed-loop automated oxygen control in preterm ventilated infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2026 Apr 17;111(3):F243-F248. doi: 10.1136/archdischild-2025-329022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity and Respiratory Distress Neonatal, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ourania Kaltsogianni, MD (Res) (0044+02032999000 ext. 38494, ourania.kaltsogianni@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07866820, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.