Premature InfantNCT04546568
SCO2T (Servo vs. Servo)
A study of Premature Infant and Oxygen Therapy, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is adjusted to keep the level in a target range. Read more about this study
- Who is it for?
- Ages 2 days and olderHealthy volunteers can take part
- Conditions the study is for
- Premature Infant, Oxygen Therapy, Hypoxia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Aug 2020to 3 May 2023
- 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 2 days and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Infants born at less than 30 weeks gestation
- Infants greater than 48 hours of age
- Infants who are receiving supplementary oxygen
- Person with parental responsibility able to give consent
Who cannot join
- Congenital anomalies that would prevent targeting SpO2 to 90-95% (e.g. cardiac defects)
- Clinical condition of an infant would impair accurateTcPO2 measurement (e.g. impaired perfusion or requirement of inotropic or vasopressor support)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Simpson Centre for Reproductive Health, Royal Infirmary Edinburgh
Edinburgh, City Of Edinburgh, EH16 4SA
About this study
Official title: Servo Controlled Oxygen Targeting (SCO2T): Servo Versus Servo
Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is adjusted to keep the level in a target range. Although there is evidence that lower oxygen levels maybe harmful, it is not known how high they need to be for maximum benefit. Very high levels are also harmful. Saturation monitors are not very good for checking for high oxygen levels. For this a different kind of monitor, called a transcutaneous monitor, is better.
Keeping oxygen levels stable is usually done by nurses adjusting the oxygen levels by hand (manual control). There is also equipment available that can do this automatically (servo control). It is not known which is best.
Read more
Studies of automated control have shown that infants spend more time within their intended target oxygen saturation range. These have not included measurements of transcutaneous oxygen. There are no previous studies directly comparing automated respiratory devices.
The investigators aim to show the transcutaneous oxygen levels as well as the oxygen saturation levels when babies have their oxygen adjusted using two automated (servo) control devices delivering nasal high flow.
For a period of 12 hours each baby will have their oxygen adjusted automatically using each devices for 6 hours respectively. The investigators will compare the range of oxygen levels that are seen between the two respiratory devices.
Read the detailed description
Presently oxygen is titrated against saturation (SpO2) by manual adjustment. Automated or servo-control systems have been developed that result in tighter control of SpO2 and more time spent in the intended target range. These systems are already in clinical use. Automated systems produce quite large fluctuations in fraction of inspired oxygen (FiO2) in order to keep SpO2 in range. It is possible that this could result in short periods of high or low oxygen tension (PO2) that are undetectable using saturation monitoring. Studies to date have examined the effects of manual and automated (servo) oxygen targeting on SpO2 but not on transcutaneous oxygen tension (TcPO2). There are no studies directly comparing two automated systems.
There is a need to determine the achieved SpO2 and TcPO2 distributions associated with the use of different automated control systems as a first step in planning future trials. When this is measured over a small number of hours it is not anticipated that this would have an influence on clinical outcome.
This study is a prospective, single centre, randomised crossover trial of two automated (servo) control devices - IntellO2 (Vapotherm, USA) versus Leoni plus CLAC (Löwenstein Medical, Germany) - delivering nasal high flow employing automated oxygen titration. Each infant will act as their own control. Infants born at less than 30 weeks gestation, greater than 48 hour of age and receiving supplementary oxygen will be eligible for inclusion.
The study will be undertaken in the Neonatal Unit at the Simpson Centre for Reproductive Health at the Royal Infirmary of Edinburgh.
Total study time is 12 hours for each infant. Infants will be randomised to commence on either automated (servo) control using either Leoni plus CLAC or IntellO2, Vapotherm. SpO2 (range 90-95%) will be continuously monitored as per normal standard of care. A second pulse oximetry probe will be place for servo control input.
Additional monitoring will be carried out as shown below:
- TcPO2 monitoring
- FiO2 monitoring
- Heart rate monitoring (used to validate SpO2 readings)
- Arterial gas sampling (only if conducted by the direct care team as part of the routine care of the infant; no extra blood samples will be taken as part of the study)
FiO2 will be adjusted by the respiratory support devices which have integrated automated oxygen control, set to maintain a SpO2 target range of 90-95%. The IntellO2 device uses Precision Flow technology (IntellO2, Vapotherm, USA). By means of a modified closed-loop algorithm, the devise uses Masimo pulse oximetry to target a user-set SpO2 value. The Leoni plus CLAC (Closed-Loop Automated oxygen Control) ventilator (Leoni plus, Löwenstein Medical, Germany) similarly uses MasimoSET (Signal Extraction Technology) to target SpO2 and automate oxygen control. Both devices have a signal averaging time of 8 seconds (Masimo, Irvine, USA). The Leoni plus CLAC algorithm is set to a 30 seconds wait time between adjustments, allowing up to 120 automated adjustments/hour.
SpO2 readings will be downloaded directly from the multiparameter patient monitor. SpO2 will be measured using a Phillips MX500 multiparameter monitor (Phillips, Germany, CE 0366). TcPO2 will be measured using a SenTec Digital Monitoring System with OxiVent sensor (SenTec AG, Switzerland, European patent No. 1535055, CE 0120). Both monitors are routinely used in clinical practice. Transcutaneous data will be recorded contemporaneously and the site of the transcutaneous probe will be rotated on each infant every 2 hours. Control of sensor temperature and application duration are designed to meet all applicable standards and this monitoring device is use routinely in many neonatal units.
- Conditions
- Premature Infant, Oxygen Therapy, Hypoxia, Hyperoxia, Obstetric Labor, Premature
- Being tested
- Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - Leoni plus CLAC, Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAM
- Keywords
- Servo Control, Close-Loop Automated Oxygen Control
- Medical subject headings
- Premature Birth, Hypoxia, Hyperoxia, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - Leoni plus CLACDevice
FiO2 adjustments will be made by the Leoni plus CLAC (Closed-Loop Automated oxygen Control) ventilator (Leoni plus, Löwenstein Medical, Germany).
Manual adjustments of the inspired oxygen fraction can additionally be made as per standard care.
Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAMDevice
FiO2 adjustments will be made by the IntellO2 Oxygen Assist Module (OAM) for Precision Flow (IntellO2, Vapotherm, USA).
Manual adjustments of the inspired oxygen fraction can additionally be made as per standard care.
| Study group | Role | What they receive |
|---|---|---|
| Servo control - Leoni plus CLAC | Experimental | Automated control of oxygen. The oxygen saturation target range will be set to 90-95% as per standard practice.
Automated oxygen control can be overridden by manual adjustment of oxygen at any time if this is considered necessary to optimise control of oxygenation according to current clinical targets. Receives: Device: Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - Leoni plus CLAC |
| Servo control - IntellO2 Precision Flow, Vapotherm | Active comparator | Automated control of oxygen. The oxygen saturation target range will be set to 90-95% (set to maintain an integral value of 93%) as per standard practice.
Automated oxygen control can be overridden by manual adjustment of oxygen at any time if this is considered necessary to optimise control of oxygenation according to current clinical targets. Receives: Device: Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hyperoxia and hypoxia on transcutaneous monitoring
To discover the percentage time spent within a TcPO2 range of 50mmHg (6.7kPa) - 80mmHg (10.7kPa) when infants are targeted to an SpO2 range of 90-95% using two automated (servo) control devices (Leoni plus CLAC and Vapotherm IntellO2) delivering nasal high flow.
Measured: 12 hours
Secondary outcomes (8)
Transcutanous oxygen variability
To discover the variability in TcPO2 (measured by standard deviation) when infants are targeted to an SpO2 range of 90-95% using the two automated (servo) control devices delivering nasal high flow.
Measured: 12 hours
Incidence of hyperoxia and hypoxia on saturation monitoring
To discover the percentage time spent within target SpO2 range of 90-95% when infants are targeted using the two automated (servo) control devices delivering nasal high flow.
Measured: 12 hours
Saturation variability
To discover the variability in SpO2 (measured by standard deviation) when infants are targeted to an SpO2 range of 90-95% using the two automated (servo) control devices delivering nasal high flow.
Measured: 12 hours
Fraction of inspired oxygen variability
To discover the variability in FiO2 (measured by standard deviation) when infants are targeted to an SpO2 range of 90-95% using the two automated (servo) control devices delivering nasal high flow.
Measured: 12 hours
Pooled frequency histogram of TcPO2
To generate a pooled frequency histogram of percentage time at a TcPO2 of below 30mmHg, 30-39.9mmHg, 40-49.9mmHg, 50-59.9mmHg, 60-69.9mmHg, 70-79.9mmHg, and 80mmHg and above for infants targeted to an SpO2 range of 90-95% using the two automated (servo) control devices delivering nasal high flow.
Measured: 12 hours
Pooled frequency histogram of SpO2
To generate a pooled frequency histogram of percentage time at each SpO2 point between 80 - 100% for infants targeted to an SpO2 range of 90-95% using the two automated (servo) control devices delivering nasal high flow.
Measured: 12 hours
Pooled frequency histogram of FiO2
To generate a pooled frequency histogram of the cumulative frequency at a FiO2 of 0.21-0.3, 0.31-0.4, 0.41-0.5, 0.51-0.6, 0.61-0.7, 0.81-0.9 and 0.91-1.0 for infants targeted to an SpO2 range of 90-95% using the two automated (servo) control devices delivering nasal high flow.
Measured: 12 hours
Desaturations
To discover the frequency, duration and depth of desaturations and the area (change in PO2 versus time) above and below the set PO2 threshold for infants targeted to an SpO2 range of 90-95% using the two automated (servo) control devices delivering nasal high flow.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start10 Aug 2020
- Primary completion3 May 2023
- Study completion3 May 2023
Why it stopped: Failed to meet recruitment target
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomised cross-over study of servo-controlled oxygen targeting in premature infants, with infants acting as their own controls
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546568
- Sponsor's protocol ID
- AC20034
- Status last verified
- May 2022
- First submitted
- 4 Sep 2020
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Servo Controlled Oxygen Targeting (SCO2T): Servo Versus Servo
- ClinicalTrials.gov ID
- NCT04546568
- Acronym / sponsor ID
- AC20034
- Conditions
- Premature Infant, Oxygen Therapy, Hypoxia, Hyperoxia, Obstetric Labor, Premature
- Keywords
- Servo Control, Close-Loop Automated Oxygen Control
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to meet recruitment target
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 14 Sep 2020 (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.
Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is adjusted to keep the level in a target range. Although there is evidence that lower oxygen levels maybe harmful, it is not known how high they need to be for maximum benefit. Very high levels are also harmful. Saturation monitors are not very good for checking for high oxygen levels. For this a different kind of monitor, called a transcutaneous monitor, is better.
Keeping oxygen levels stable is usually done by nurses adjusting the oxygen levels by hand (manual control). There is also equipment available that can do this automatically (servo control). It is not known which is best.
Studies of automated control have shown that infants spend more time within their intended target oxygen saturation range. These have not included measurements of transcutaneous oxygen. There are no previous studies directly comparing automated respiratory devices.
The investigators aim to show the transcutaneous oxygen levels as well as the oxygen saturation levels when babies have their oxygen adjusted using two automated (servo) control devices delivering nasal high flow.
For a period of 12 hours each baby will have their oxygen adjusted automatically using each devices for 6 hours respectively. The investigators will compare the range of oxygen levels that are seen between the two respiratory devices.
Detailed description
Presently oxygen is titrated against saturation (SpO2) by manual adjustment. Automated or servo-control systems have been developed that result in tighter control of SpO2 and more time spent in the intended target range. These systems are already in clinical use. Automated systems produce quite large fluctuations in fraction of inspired oxygen (FiO2) in order to keep SpO2 in range. It is possible that this could result in short periods of high or low oxygen tension (PO2) that are undetectable using saturation monitoring. Studies to date have examined the effects of manual and automated (servo) oxygen targeting on SpO2 but not on transcutaneous oxygen tension (TcPO2). There are no studies directly comparing two automated systems.
There is a need to determine the achieved SpO2 and TcPO2 distributions associated with the use of different automated control systems as a first step in planning future trials. When this is measured over a small number of hours it is not anticipated that this would have an influence on clinical outcome.
This study is a prospective, single centre, randomised crossover trial of two automated (servo) control devices - IntellO2 (Vapotherm, USA) versus Leoni plus CLAC (Löwenstein Medical, Germany) - delivering nasal high flow employing automated oxygen titration. Each infant will act as their own control. Infants born at less than 30 weeks gestation, greater than 48 hour of age and receiving supplementary oxygen will be eligible for inclusion.
The study will be undertaken in the Neonatal Unit at the Simpson Centre for Reproductive Health at the Royal Infirmary of Edinburgh.
Total study time is 12 hours for each infant. Infants will be randomised to commence on either automated (servo) control using either Leoni plus CLAC or IntellO2, Vapotherm. SpO2 (range 90-95%) will be continuously monitored as per normal standard of care. A second pulse oximetry probe will be place for servo control input.
Additional monitoring will be carried out as shown below:
- TcPO2 monitoring
- FiO2 monitoring
- Heart rate monitoring (used to validate SpO2 readings)
- Arterial gas sampling (only if conducted by the direct care team as part of the routine care of the infant; no extra blood samples will be taken as part of the study)
FiO2 will be adjusted by the respiratory support devices which have integrated automated oxygen control, set to maintain a SpO2 target range of 90-95%. The IntellO2 device uses Precision Flow technology (IntellO2, Vapotherm, USA). By means of a modified closed-loop algorithm, the devise uses Masimo pulse oximetry to target a user-set SpO2 value. The Leoni plus CLAC (Closed-Loop Automated oxygen Control) ventilator (Leoni plus, Löwenstein Medical, Germany) similarly uses MasimoSET (Signal Extraction Technology) to target SpO2 and automate oxygen control. Both devices have a signal averaging time of 8 seconds (Masimo, Irvine, USA). The Leoni plus CLAC algorithm is set to a 30 seconds wait time between adjustments, allowing up to 120 automated adjustments/hour.
SpO2 readings will be downloaded directly from the multiparameter patient monitor. SpO2 will be measured using a Phillips MX500 multiparameter monitor (Phillips, Germany, CE 0366). TcPO2 will be measured using a SenTec Digital Monitoring System with OxiVent sensor (SenTec AG, Switzerland, European patent No. 1535055, CE 0120). Both monitors are routinely used in clinical practice. Transcutaneous data will be recorded contemporaneously and the site of the transcutaneous probe will be rotated on each infant every 2 hours. Control of sensor temperature and application duration are designed to meet all applicable standards and this monitoring device is use routinely in many neonatal units.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomised cross-over study of servo-controlled oxygen targeting in premature infants, with infants acting as their own controls
| Arm | Type | Receives |
|---|---|---|
| Servo control - Leoni plus CLAC | Experimental | Device: Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - Leoni plus CLACAutomated control of oxygen. The oxygen saturation target range will be set to 90-95% as per standard practice. Automated oxygen control can be overridden by manual adjustment of oxygen at any time if this is considered necessary to optimise control of oxygenation according to current clinical targets. |
| Servo control - IntellO2 Precision Flow, Vapotherm | Active comparator | Device: Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAMAutomated control of oxygen. The oxygen saturation target range will be set to 90-95% (set to maintain an integral value of 93%) as per standard practice. Automated oxygen control can be overridden by manual adjustment of oxygen at any time if this is considered necessary to optimise control of oxygenation according to current clinical targets. |
Who may qualify
- Ages
- 2 days and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Infants born at less than 30 weeks gestation
- Infants greater than 48 hours of age
- Infants who are receiving supplementary oxygen
- Person with parental responsibility able to give consent
Key exclusion criteria (2 listed)
- Congenital anomalies that would prevent targeting SpO2 to 90-95% (e.g. cardiac defects)
- Clinical condition of an infant would impair accurateTcPO2 measurement (e.g. impaired perfusion or requirement of inotropic or vasopressor support)
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 |
|---|---|---|
| Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - Leoni plus CLACFiO2 adjustments will be made by the Leoni plus CLAC (Closed-Loop Automated oxygen Control) ventilator (Leoni plus, Löwenstein Medical, Germany). Manual adjustments of the inspired oxygen fraction can additionally be made as per standard care. | Device | Servo control - Leoni plus CLAC |
| Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAMFiO2 adjustments will be made by the IntellO2 Oxygen Assist Module (OAM) for Precision Flow (IntellO2, Vapotherm, USA). Manual adjustments of the inspired oxygen fraction can additionally be made as per standard care. | Device | Servo control - IntellO2 Precision Flow, Vapotherm |
Primary outcome
Incidence of hyperoxia and hypoxia on transcutaneous monitoring
Time frame: 12 hours
To discover the percentage time spent within a TcPO2 range of 50mmHg (6.7kPa) - 80mmHg (10.7kPa) when infants are targeted to an SpO2 range of 90-95% using two automated (servo) control devices (Leoni plus CLAC and Vapotherm IntellO2) delivering nasal high flow.
8 secondary outcomes
Transcutanous oxygen variability
Time frame: 12 hours
Incidence of hyperoxia and hypoxia on saturation monitoring
Time frame: 12 hours
Saturation variability
Time frame: 12 hours
Fraction of inspired oxygen variability
Time frame: 12 hours
Pooled frequency histogram of TcPO2
Time frame: 12 hours
Pooled frequency histogram of SpO2
Time frame: 12 hours
Pooled frequency histogram of FiO2
Time frame: 12 hours
Desaturations
Time frame: 12 hours
Results and safety
The study was stopped early (reason given: Failed to meet recruitment target). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
Related trials for Premature Infant
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Recruiting
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Premature Infant and Oxygen Therapy, run by University of Edinburgh 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 2 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: stopped early, as of the sponsor's last update on 2 Jun 2023. 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 was stopped early (reason given: Failed to meet recruitment target). Results are not available in the source record.
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?
Incidence of hyperoxia and hypoxia on transcutaneous monitoring (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2023.