Infant, Newborn, DiseasesNCT05657795
Optimising Neonatal Ventilation with Closed-loop Oxygen Control
A study of Infant, Newborn, Diseases and Mechanical Ventilation Complication, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Ventilated newborns frequently need supplemental oxygen but its use must be monitored carefully as both giving too much or too little oxygen can have harmful effects. Giving too little oxygen results to low oxygen levels (hypoxia) and increases the risk of complications and mortality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant, Newborn, Diseases, Mechanical Ventilation Complication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Dec 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants born at or above 34 weeks completed gestation requiring mechanical ventilation and admitted to King's NICU within 24 hours of initiation of mechanical ventilation.
Who cannot join
- Preterm infants less than 34 weeks gestation
- Infants with cyanotic congenital heart disease
- Infants on high frequency oscillatory ventilation (HFOV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Closed-loop Automated Oxygen Control During Mechanical Ventilation Reduce the Duration of Supplementary Oxygen Treatment and the Amount of Time Spent in Hyperoxia? a Randomised Trial in Ventilated Infants Born At or Near Term
Ventilated newborns frequently need supplemental oxygen but its use must be monitored carefully as both giving too much or too little oxygen can have harmful effects. Giving too little oxygen results to low oxygen levels (hypoxia) and increases the risk of complications and mortality. Excessive oxygen delivery (hyperoxia) increases the risk of diseases involving several organs such as the retinas and the lungs. Although infants born very preterm require support with their breathing more often, more mature neonates may also need to be ventilated at birth and to receive supplemental oxygen. Therefore, they may suffer from problems related to hypoxia and hyperoxia.
For the above reasons, oxygen levels are continuously monitored and the amount of oxygen provided is manually adjusted by the nurses and doctors.
Closed-loop automated oxygen control systems (CLAC) are a more recent approach that involves the use of a computer software added to the ventilator. This software allows for automatic adjustment of the amount of oxygen provided to the baby in order to maintain oxygen levels within a desired target range depending on the baby's age and clinical condition. Previous studies in preterm and very small infants showed that automated oxygen control systems provided the right amount of oxygen for most of the time and prevented hypoxia and hyperoxia with fewer manual adjustments required by clinical staff. Preliminary results from a study that included infants born at 34 weeks gestation and beyond showed that CLAC systems allowed to reduce the amount of supplementary oxygen more rapidly. With this study we aim to compare the time spent in hyperoxia and the overall duration of oxygen treatment between infants whose oxygen is adjusted either manually or automatically while they remain ventilated. This will help us understand if CLAC systems help reduce the complications related to oxygen treatment.
Read the detailed description
This will be a randomised controlled trial. The investigators aim to recruit a minimum of forty ventilated infants born at or above 34 weeks of gestation. Participants will be randomised to either closed-loop automated oxygen control or manually controlled oxygen from recruitment to successful extubation.
Informed written consent will be requested from the parents or legal guardians of the infants and the attending neonatal consultant will be requested to assent to the study.
Eligible infants whose parents consent to the study will be enrolled within 24 hours of initiation of mechanical ventilation.
Randomisation will be performed using an online randomisation generator. Patients will be ventilated using SLE6000 ventilators. Ventilator settings will be manually adjusted by the clinical team as per unit's protocol. The intervention group, in addition to standard care will also be connected to the Oxygenie closed-loop oxygen saturation monitoring software (SLE). This software uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments to the inspired oxygen concentration will be allowed at any point during the study if deemed appropriate by the clinical team.
Patient will be studied from enrolment till successful extubation. If an infant fails extubation and required reintubation within 48 hours, he will be studied in his initial study arm. Therefore, for the infants randomised at the intervention group CLAC will resume.
- Being tested
- Closed-loop automated oxygen control (Oxygenie, SLE6000)
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop automated oxygen control (Oxygenie, SLE6000)Device
The OxyGenie closed-loop oxygen saturation monitoring software (SLE) uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments including the percentage of FiO2 will be allowed at any point during the study if deemed appropriate by the clinical team.
| Study group | Role | What they receive |
|---|---|---|
| Manual oxygen control | No intervention | Standard ventilation with inspired oxygen concentration adjusted manually as per unit's protocol. |
| Closed-loop automated oxygen control (Oxygenie, SLE 6000) | Other | Ventilation with Oxygenie software (closed-loop automated oxygen control system), adjusted by clinical staff as necessary Receives: Device: Closed-loop automated oxygen control (Oxygenie, SLE6000) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of oxygen treatment
The duration of oxygen treatment will be measured in median (interquartile range) number of days of oxygen treatment for participants in each group.
Measured: Through study completion, an average of 1 year
The percentage of time spent in hyperoxia
Target oxygen saturation range for our study population is 92-96%. Hyperoxia is defined as the time spent with oxygen saturation levels exceeding 96%. The time spent in hyperoxia will be calculated as a percentage of the total time of monitoring.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
The percentage of time spent receiving an inspired oxygen concentration (FiO2) above 30%
The time spent with an FiO2>30% will be calculated as a percentage of the total time of monitoring.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start7 Dec 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Infant, Newborn, DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating infants will be randomised either to manual oxygen control or closed-loop automated oxygen control, adjusted by clinical staff as necessary.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Theodore Dassios, PhD, Principal investigator, King's College Hospital/ King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657795
- Sponsor's protocol ID
- KCH22-163
- Status last verified
- Feb 2025
- First submitted
- 12 Dec 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramadan G, Paul N, Morton M, Peacock JL, Greenough A. Outcome of ventilated infants born at term without major congenital abnormalities. Eur J Pediatr. 2012 Feb;171(2):331-6. doi: 10.1007/s00431-011-1549-8. Epub 2011 Aug 11.
PubMed 21833494Williams LZJ, McNamara D, Alsweiler JM. Intermittent Hypoxemia in Infants Born Late Preterm: A Prospective Cohort Observational Study. J Pediatr. 2019 Jan;204:89-95.e1. doi: 10.1016/j.jpeds.2018.08.048. Epub 2018 Oct 1.
PubMed 30287066Lakshminrusimha S, Konduri GG, Steinhorn RH. Considerations in the management of hypoxemic respiratory failure and persistent pulmonary hypertension in term and late preterm neonates. J Perinatol. 2016 Jun;36 Suppl 2:S12-9. doi: 10.1038/jp.2016.44.
PubMed 27225960Salverda HH, Cramer SJE, Witlox RSGM, Dargaville PA, Te Pas AB. Automated oxygen control in preterm infants, how does it work and what to expect: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2021 Mar;106(2):215-221. doi: 10.1136/archdischild-2020-318918. Epub 2020 Jul 30.
PubMed 32732378Sturrock S, Ambulkar H, Williams EE, Sweeney S, Bednarczuk NF, Dassios T, Greenough A. A randomised crossover trial of closed loop automated oxygen control in preterm, ventilated infants. Acta Paediatr. 2021 Mar;110(3):833-837. doi: 10.1111/apa.15585. Epub 2020 Oct 6.
PubMed 32969040Abdo M, Hanbal A, Asla MM, Ishqair A, Alfar M, Elnaiem W, Ragab KM, Nourelden AZ, Zaazouee MS. Automated versus manual oxygen control in preterm infants receiving respiratory support: a systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6069-6076. doi: 10.1080/14767058.2021.1904875. Epub 2021 Apr 8.
PubMed 33832390Kaltsogianni O, Dassios T, Jenkinson A, Greenough A. Does closed-loop automated oxygen control reduce the duration of supplementary oxygen treatment and the amount of time spent in hyperoxia? A randomised controlled trial in ventilated infants born at or near term. Trials. 2023 Jun 15;24(1):404. doi: 10.1186/s13063-023-07415-9.
PubMed 37316885
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Closed-loop Automated Oxygen Control During Mechanical Ventilation Reduce the Duration of Supplementary Oxygen Treatment and the Amount of Time Spent in Hyperoxia? a Randomised Trial in Ventilated Infants Born At or Near Term
- ClinicalTrials.gov ID
- NCT05657795
- Acronym / sponsor ID
- KCH22-163
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 20 Dec 2022 (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.
Ventilated newborns frequently need supplemental oxygen but its use must be monitored carefully as both giving too much or too little oxygen can have harmful effects. Giving too little oxygen results to low oxygen levels (hypoxia) and increases the risk of complications and mortality. Excessive oxygen delivery (hyperoxia) increases the risk of diseases involving several organs such as the retinas and the lungs. Although infants born very preterm require support with their breathing more often, more mature neonates may also need to be ventilated at birth and to receive supplemental oxygen. Therefore, they may suffer from problems related to hypoxia and hyperoxia.
For the above reasons, oxygen levels are continuously monitored and the amount of oxygen provided is manually adjusted by the nurses and doctors.
Closed-loop automated oxygen control systems (CLAC) are a more recent approach that involves the use of a computer software added to the ventilator. This software allows for automatic adjustment of the amount of oxygen provided to the baby in order to maintain oxygen levels within a desired target range depending on the baby's age and clinical condition. Previous studies in preterm and very small infants showed that automated oxygen control systems provided the right amount of oxygen for most of the time and prevented hypoxia and hyperoxia with fewer manual adjustments required by clinical staff. Preliminary results from a study that included infants born at 34 weeks gestation and beyond showed that CLAC systems allowed to reduce the amount of supplementary oxygen more rapidly. With this study we aim to compare the time spent in hyperoxia and the overall duration of oxygen treatment between infants whose oxygen is adjusted either manually or automatically while they remain ventilated. This will help us understand if CLAC systems help reduce the complications related to oxygen treatment.
Detailed description
This will be a randomised controlled trial. The investigators aim to recruit a minimum of forty ventilated infants born at or above 34 weeks of gestation. Participants will be randomised to either closed-loop automated oxygen control or manually controlled oxygen from recruitment to successful extubation.
Informed written consent will be requested from the parents or legal guardians of the infants and the attending neonatal consultant will be requested to assent to the study.
Eligible infants whose parents consent to the study will be enrolled within 24 hours of initiation of mechanical ventilation.
Randomisation will be performed using an online randomisation generator. Patients will be ventilated using SLE6000 ventilators. Ventilator settings will be manually adjusted by the clinical team as per unit's protocol. The intervention group, in addition to standard care will also be connected to the Oxygenie closed-loop oxygen saturation monitoring software (SLE). This software uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments to the inspired oxygen concentration will be allowed at any point during the study if deemed appropriate by the clinical team.
Patient will be studied from enrolment till successful extubation. If an infant fails extubation and required reintubation within 48 hours, he will be studied in his initial study arm. Therefore, for the infants randomised at the intervention group CLAC will resume.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participating infants will be randomised either to manual oxygen control or closed-loop automated oxygen control, adjusted by clinical staff as necessary.
| Arm | Type | Receives |
|---|---|---|
| Manual oxygen control | No intervention | –Standard ventilation with inspired oxygen concentration adjusted manually as per unit's protocol. |
| Closed-loop automated oxygen control (Oxygenie, SLE 6000) | Other | Device: Closed-loop automated oxygen control (Oxygenie, SLE6000)Ventilation with Oxygenie software (closed-loop automated oxygen control system), adjusted by clinical staff as necessary |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Infants born at or above 34 weeks completed gestation requiring mechanical ventilation and admitted to King's NICU within 24 hours of initiation of mechanical ventilation.
Key exclusion criteria (3 listed)
- Preterm infants less than 34 weeks gestation
- Infants with cyanotic congenital heart disease
- Infants on high frequency oscillatory ventilation (HFOV)
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 |
|---|---|---|
| Closed-loop automated oxygen control (Oxygenie, SLE6000)The OxyGenie closed-loop oxygen saturation monitoring software (SLE) uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments including the percentage of FiO2 will be allowed at any point during the study if deemed appropriate by the clinical team. | Device | Closed-loop automated oxygen control (Oxygenie, SLE 6000) |
Primary outcome
The duration of oxygen treatment
Time frame: Through study completion, an average of 1 year
The duration of oxygen treatment will be measured in median (interquartile range) number of days of oxygen treatment for participants in each group.
The percentage of time spent in hyperoxia
Time frame: Through study completion, an average of 1 year
Target oxygen saturation range for our study population is 92-96%. Hyperoxia is defined as the time spent with oxygen saturation levels exceeding 96%. The time spent in hyperoxia will be calculated as a percentage of the total time of monitoring.
1 secondary outcome
The percentage of time spent receiving an inspired oxygen concentration (FiO2) above 30%
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Background: PubMed 21833494Ramadan G, Paul N, Morton M, Peacock JL, Greenough A. Outcome of ventilated infants born at term without major congenital abnormalities. Eur J Pediatr. 2012 Feb;171(2):331-6. doi: 10.1007/s00431-011-1549-8. Epub 2011 Aug 11.
- Background: PubMed 30287066Williams LZJ, McNamara D, Alsweiler JM. Intermittent Hypoxemia in Infants Born Late Preterm: A Prospective Cohort Observational Study. J Pediatr. 2019 Jan;204:89-95.e1. doi: 10.1016/j.jpeds.2018.08.048. Epub 2018 Oct 1.
- Background: PubMed 27225960Lakshminrusimha S, Konduri GG, Steinhorn RH. Considerations in the management of hypoxemic respiratory failure and persistent pulmonary hypertension in term and late preterm neonates. J Perinatol. 2016 Jun;36 Suppl 2:S12-9. doi: 10.1038/jp.2016.44.
- Background: PubMed 32732378Salverda HH, Cramer SJE, Witlox RSGM, Dargaville PA, Te Pas AB. Automated oxygen control in preterm infants, how does it work and what to expect: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2021 Mar;106(2):215-221. doi: 10.1136/archdischild-2020-318918. Epub 2020 Jul 30.
- Background: PubMed 32969040Sturrock S, Ambulkar H, Williams EE, Sweeney S, Bednarczuk NF, Dassios T, Greenough A. A randomised crossover trial of closed loop automated oxygen control in preterm, ventilated infants. Acta Paediatr. 2021 Mar;110(3):833-837. doi: 10.1111/apa.15585. Epub 2020 Oct 6.
- Background: PubMed 33832390Abdo M, Hanbal A, Asla MM, Ishqair A, Alfar M, Elnaiem W, Ragab KM, Nourelden AZ, Zaazouee MS. Automated versus manual oxygen control in preterm infants receiving respiratory support: a systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6069-6076. doi: 10.1080/14767058.2021.1904875. Epub 2021 Apr 8.
- Derived from this study: PubMed 37316885Kaltsogianni O, Dassios T, Jenkinson A, Greenough A. Does closed-loop automated oxygen control reduce the duration of supplementary oxygen treatment and the amount of time spent in hyperoxia? A randomised controlled trial in ventilated infants born at or near term. Trials. 2023 Jun 15;24(1):404. doi: 10.1186/s13063-023-07415-9.
- 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. This study is not recruiting at the moment.
Theodore Dassios, PhD principal investigator
King's College Hospital/ King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Infant, Newborn, Diseases and Mechanical Ventilation Complication, 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 10 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of oxygen treatment (time frame: Through study completion, an average of 1 year). 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 NCT05657795, which also lists 7 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 10 Mar 2025.