Premature InfantSCO2TNCT04177992
Servo Controlled Oxygen Targeting Study
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 Up to 1 month
- Conditions the study is for
- Premature Infant, Oxygen Therapy, Hypoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jan 2020to 6 Jan 2021
- 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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born at less than 29 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, EH16 4SA
About this study
Official title: Randomised Cross-over Study of Servo-controlled Oxygen Targeting for Premature Infants
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.
The investigators aim to show the transcutaneous oxygen levels as well as the oxygen saturation levels when babies have their oxygen adjusted manually or automatically.
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 is a need to determine the achieved SpO2 and TcPO2 distributions associated with the use of manual and automated control as a first step in planning trials comparing these approaches over many weeks. 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 automated (servo) control versus manual oxygen titration. Each infant will act as their own control. Infants born at less than 29 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 or manual mode. 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)
In manual mode, all oxygen adjustments will be made by clinical/nursing staff. In automated mode, oxygen will be adjusted by the respiratory support device.
In automated mode (servo control), oxygen adjustments will be made by one of two devices (depending on the clinical requirements of the baby) - the IntellO2 device (IntellO2, Vapotherm) or Leoni plus CLAC (Closed-Loop Automated oxygen Control) ventilator (Leoni plus, Löwenstein Medical).
SpO2 and TcPO2 readings will be downloaded directly from the multiparameter patient monitor. SpO2 will be measured using a Phillips MX500 multiparameter monitor. TcPO2 will be measured using a SenTec Digital Monitoring System with OxiVent sensor. TcPO2 is calculated by dynamic fluorescence quenching which measures oxygen molecules present in the vicinity of a fluorescent dye incorporated within the sensor surface. The sensor is operated at a constant temperature of 43 degrees Celsius. Control of sensor temperature and application duration are designed to meet all applicable standards and this monitoring device is used routinely in many neonatal units.
- Conditions
- Premature Infant, Oxygen Therapy, Hypoxia, Hyperoxia, Obstetric Labor, Premature
- Being tested
- Servo control
- Keywords
- Neonatology, Servo-control, Transcutaneous oxygen, Saturation monitoring
- 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 controlOther
FiO2 adjustments will be made by one of two respiratory devices depending on the clinical requirements and current ventilatory therapy of the infant
| Study group | Role | What they receive |
|---|---|---|
| Servo control | Experimental | Automated control of oxygen. The oxygen saturation target range will be set to 93%.
Automated oxygen control can be over-ridden by manual adjustment of oxygen at any time if this is considered necessary to optimise control of oxygenation according to current clinical targets. Receives: Other: Servo control |
| Manual control | No intervention | Standard practice. Oxygen adjustments will be made by clinical/nursing staff to maintain a target oxygen range of 90%-95%. |
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 automated (servo) versus manual control.
Measured: 12 hours
Secondary outcomes (8)
Transcutaneous oxygen variability
To discover the variability in TcPO2 (measured by standard deviation) when infants are targeted to an SpO2 range of 90-95% using automated (servo) versus manual control.
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 automated (servo) versus manual control.
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 automated (servo) versus manual control.
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 automated (servo) versus manual control.
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 automated (servo) versus manual control.
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 automated (servo) versus manual control.
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 automated (servo) versus manual control.
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 automated (servo) versus manual control.
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 posted26 Nov 2019
- Study start16 Jan 2020
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
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
- 22 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
- NCT04177992
- Sponsor's protocol ID
- AC19110
- Acronym
- SCO2T
- Status last verified
- Jan 2021
- First submitted
- 22 Nov 2019
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Cross-over Study of Servo-controlled Oxygen Targeting for Premature Infants
- ClinicalTrials.gov ID
- NCT04177992
- Acronym / sponsor ID
- SCO2T / AC19110
- Conditions
- Premature Infant, Oxygen Therapy, Hypoxia, Hyperoxia, Obstetric Labor, Premature
- Keywords
- Neonatology, Servo-control, Transcutaneous oxygen, Saturation monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 26 Nov 2019 (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.
The investigators aim to show the transcutaneous oxygen levels as well as the oxygen saturation levels when babies have their oxygen adjusted manually or automatically.
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 is a need to determine the achieved SpO2 and TcPO2 distributions associated with the use of manual and automated control as a first step in planning trials comparing these approaches over many weeks. 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 automated (servo) control versus manual oxygen titration. Each infant will act as their own control. Infants born at less than 29 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 or manual mode. 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)
In manual mode, all oxygen adjustments will be made by clinical/nursing staff. In automated mode, oxygen will be adjusted by the respiratory support device.
In automated mode (servo control), oxygen adjustments will be made by one of two devices (depending on the clinical requirements of the baby) - the IntellO2 device (IntellO2, Vapotherm) or Leoni plus CLAC (Closed-Loop Automated oxygen Control) ventilator (Leoni plus, Löwenstein Medical).
SpO2 and TcPO2 readings will be downloaded directly from the multiparameter patient monitor. SpO2 will be measured using a Phillips MX500 multiparameter monitor. TcPO2 will be measured using a SenTec Digital Monitoring System with OxiVent sensor. TcPO2 is calculated by dynamic fluorescence quenching which measures oxygen molecules present in the vicinity of a fluorescent dye incorporated within the sensor surface. The sensor is operated at a constant temperature of 43 degrees Celsius. Control of sensor temperature and application duration are designed to meet all applicable standards and this monitoring device is used 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 | Experimental | Other: Servo controlAutomated control of oxygen. The oxygen saturation target range will be set to 93%. Automated oxygen control can be over-ridden by manual adjustment of oxygen at any time if this is considered necessary to optimise control of oxygenation according to current clinical targets. |
| Manual control | No intervention | –Standard practice. Oxygen adjustments will be made by clinical/nursing staff to maintain a target oxygen range of 90%-95%. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants born at less than 29 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 controlFiO2 adjustments will be made by one of two respiratory devices depending on the clinical requirements and current ventilatory therapy of the infant | Other | Servo control |
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 automated (servo) versus manual control.
8 secondary outcomes
Transcutaneous 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 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 14 Mar 2022.
- 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.
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: finished, as of the sponsor's last update on 14 Mar 2022. 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?
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 14 Mar 2022.