Premature InfantMONITORNCT03360292
Measuring Oxygenation of Newborn Infants in Targeted Oxygen Ranges
A study testing Higher target range in people with Premature Infant and Hypoxia, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
The investigators aim to measure the effect of targeting premature babies to a slightly higher oxygen saturation target range (92-97%) than routinely used, for a brief period, to plan a future larger study of the effect of this on clinical outcomes. Read more about this study
- Who is it for?
- Ages 48 hours to 1 month
- Conditions the study is for
- Premature Infant, Hypoxia, Hyperoxia
- What is being tested?
- Higher target range
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jan 2020to 17 Feb 2022
- 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 48 hours 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
Who cannot join
- Congenital anomalies that would affect oxygenation (eg. cardiac defects, congenital diaphragmatic hernia)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Neonatal Unit - Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA
About this study
Official title: Describing the Differences in Oxygen Profiles in Premature Infants of Less Than 29 Weeks Gestational Age When Targeted to an Oxygen Saturation Range 92 to 97%, Compared to 90 to 95%
The investigators aim to measure the effect of targeting premature babies to a slightly higher oxygen saturation target range (92-97%) than routinely used, for a brief period, to plan a future larger study of the effect of this on clinical outcomes.
It is still unclear exactly what levels of oxygen premature babies need - both too little or too much oxygen in the first weeks after birth may be harmful. Previous studies used saturation monitoring (SpO2), where a small probe shines light through the skin and calculates how much oxygen is carried in the blood. These studies demonstrated using an SpO2 range of 91-95% rather than 85-89% was associated with more babies surviving and fewer babies suffering from a bowel condition called necrotising enterocolitis (NEC). However, targeting oxygen higher increased the number of infants who needed treatment for an eye condition called retinopathy of prematurity (ROP).
Read more
It is possible an SpO2 range higher than 91-95% would be associated with even better survival. It is also possible that a higher range might not improve survival but could increase the need for ROP treatment.
Infants born at less than 29 weeks gestation, greater than 48 hours of age and receiving supplementary oxygen would be eligible for inclusion. The study is at the Royal Infirmary of Edinburgh. Total study time is 12 hours for each infant (6 hours at the standard 90-95% range used in our unit, and 6 hours at 92-97%). It is a crossover study with infants acting as their own controls.
Based on previous research the investigators are confident these oxygen levels will not be dangerously high. To provide an additional measure of oxygen the investigators will also use a transcutaneous monitor for the 12 hour study period, which fastens gently to the skin and measures oxygen and carbon dioxide levels on the skin surface.
Read the detailed description
This study is a single centre randomised crossover study. Infants born at less than 29 weeks gestation, greater than 48 hours of age and receiving supplementary oxygen would be eligible for inclusion. The study is at the Royal Infirmary of Edinburgh. Total study time is 12 hours for each infant (6 hours at the standard 90-95% range used in our unit, and 6 hours at 92-97%). It is a crossover study with infants acting as their own controls.
A complete list of all monitoring that will be carried out is shown below:
- SpO2 monitoring
- TcPO2 monitoring
- Heart rate monitoring (used to validate SpO2 readings as described below)
- Arterial gas sampling (only if conducted by the direct care team as part of the routine care of the infant will these be recorded. No extra blood samples will be taken as part of the study)
Each infant will be monitored simultaneously with an SpO2 monitor and TcPo2 monitor, with data recording starting from the time the transcutaneous monitor finishes calibrating. SpO2 readings will be downloaded directly from the multiparameter patient monitor. SpO2 will be measured using a Siemens Infinity SC7000 multiparameter monitor. This monitor uses Siemens' Oxisure pulse oximetry technology and Nellcor Oximax saturation probes and incorporates ECG to reduce motion artefact. To reduce the influence of artefact further, data from an infants chest leads (recording heart rate) will also be downloaded. If there is a greater than 10 beats per minute difference between heart rate measured from the pulse oximeter and heart rate measured from the chest leads, SpO2 for that time point will be disregarded.
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, with transcutaneous monitoring part of the monitoring equipment we use in selected infants in our unit and being transported by our local neonatal transport team. Temperature is supervised by two independent circuits, as well as by the monitor firmware.
Transcutaneous data will be transferred contemporaneously to a bedside PC via the proprietary software V-STATS (with V-CareNeT) version 4.01. We will ensure the time on the monitor is synchronised with the time displayed on the electronic patient record system recording SpO2 and heart rate. V-STATS software can identify any spurious spikes in TcPO2 caused by air bubbles and these identified segments of data will be discarded. Artefact has not significantly affected readings during the routine use of this monitor previously on our neonatal unit and with our neonatal transport team. The site of the transcutaneous probe will be rotated on each infant every 2 hours.
SpO2, TcPO2 and heart rate data will be recorded every second. The time of any arterial oxygen samples taken routinely during the study will be recorded from the unit Radiometer ABL800 FLEX blood gas analyser.
- Conditions
- Premature Infant, Hypoxia, Hyperoxia
- Being tested
- Higher target range
- Keywords
- Neonatology
- Medical subject headings
- Premature Birth, Hypoxia, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher target rangeOther
Also called Using a higher oxygen saturation target range
Intervention is using a higher oxygen saturation target range than in routine practice
| Study group | Role | What they receive |
|---|---|---|
| Higher target range | Experimental | Infants will be targeted to 92-97% oxygen saturation Receives: Other: Higher target range |
| Standard target range | No intervention | Infants will be targeted to 90-95% oxygen saturation, which is the range used as routine in the Neonatal Unit involved in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hyperoxia and hypoxia on saturations
Percentage time spent above an SpO2 of 97% and below an SpO2 of 90% when infants are targeted to an SpO2 range of 92-97% compared to 90-95%
Measured: 12 hours
Secondary outcomes (6)
Incidence of hyperoxia and hypoxia on Transcutaneous monitoring
To discover the percentage time spent above a TcPO2 of 80mmHg and below a TcPO2 of 50mmHg when infants are targeted to an SpO2 range of 92-97% compared to 90-95%
Measured: 12 hours
Saturation variability
To discover the variability in SpO2 (measured by standard deviation) when infants are targeted to an SpO2 range of 92-97% compared to 90-95%
Measured: 12 hours
Transcutaneous variability
To discover the variability in TcPO2 (measured by standard deviation) when infants are targeted to an SpO2 range of 92-97% compared to 90-95%
Measured: 12 hours
Characterise PaO2 values within the two oxygen saturation target ranges
In infants who are undergoing PaO2 measurement as part of their routine care describe the PO2 values observed in the two target ranges
Measured: 12 hours
Pooled frequency histogram of SpO2
To generate a pooled frequency histogram of percentage time at each SpO2 point between 80 and 100% for infants targeted to an SpO2 range of 92-97% compared to 90-95%
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 92-97% compared to 90-95%
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 posted4 Dec 2017
- Study start18 Jan 2020
- Primary completion18 May 2021
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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 oxygen target ranges in premature infants, with infants acting as their own controls.
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT03360292
- Sponsor's protocol ID
- AC17098
- Other IDs
- 194632
- Acronym
- MONITOR
- Status last verified
- Sep 2019
- First submitted
- 27 Nov 2017
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christie FG, Kelly R, Boardman JP, Stenson BJ. Measuring Oxygenation in Newborn Infants with Targeted Oxygen Ranges (MONITOR): a randomised crossover pilot study. Arch Dis Child Fetal Neonatal Ed. 2023 Nov;108(6):638-642. doi: 10.1136/archdischild-2022-324833. Epub 2023 May 4.
PubMed 37142388
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Describing the Differences in Oxygen Profiles in Premature Infants of Less Than 29 Weeks Gestational Age When Targeted to an Oxygen Saturation Range 92 to 97%, Compared to 90 to 95%
- ClinicalTrials.gov ID
- NCT03360292
- Acronym / sponsor ID
- MONITOR / AC17098
- Conditions
- Premature Infant, Hypoxia, Hyperoxia
- Keywords
- Neonatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 18 Jan 2020 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 4 Dec 2017 (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.
The investigators aim to measure the effect of targeting premature babies to a slightly higher oxygen saturation target range (92-97%) than routinely used, for a brief period, to plan a future larger study of the effect of this on clinical outcomes.
It is still unclear exactly what levels of oxygen premature babies need - both too little or too much oxygen in the first weeks after birth may be harmful. Previous studies used saturation monitoring (SpO2), where a small probe shines light through the skin and calculates how much oxygen is carried in the blood. These studies demonstrated using an SpO2 range of 91-95% rather than 85-89% was associated with more babies surviving and fewer babies suffering from a bowel condition called necrotising enterocolitis (NEC). However, targeting oxygen higher increased the number of infants who needed treatment for an eye condition called retinopathy of prematurity (ROP).
It is possible an SpO2 range higher than 91-95% would be associated with even better survival. It is also possible that a higher range might not improve survival but could increase the need for ROP treatment.
Infants born at less than 29 weeks gestation, greater than 48 hours of age and receiving supplementary oxygen would be eligible for inclusion. The study is at the Royal Infirmary of Edinburgh. Total study time is 12 hours for each infant (6 hours at the standard 90-95% range used in our unit, and 6 hours at 92-97%). It is a crossover study with infants acting as their own controls.
Based on previous research the investigators are confident these oxygen levels will not be dangerously high. To provide an additional measure of oxygen the investigators will also use a transcutaneous monitor for the 12 hour study period, which fastens gently to the skin and measures oxygen and carbon dioxide levels on the skin surface.
Detailed description
This study is a single centre randomised crossover study. Infants born at less than 29 weeks gestation, greater than 48 hours of age and receiving supplementary oxygen would be eligible for inclusion. The study is at the Royal Infirmary of Edinburgh. Total study time is 12 hours for each infant (6 hours at the standard 90-95% range used in our unit, and 6 hours at 92-97%). It is a crossover study with infants acting as their own controls.
A complete list of all monitoring that will be carried out is shown below:
- SpO2 monitoring
- TcPO2 monitoring
- Heart rate monitoring (used to validate SpO2 readings as described below)
- Arterial gas sampling (only if conducted by the direct care team as part of the routine care of the infant will these be recorded. No extra blood samples will be taken as part of the study)
Each infant will be monitored simultaneously with an SpO2 monitor and TcPo2 monitor, with data recording starting from the time the transcutaneous monitor finishes calibrating. SpO2 readings will be downloaded directly from the multiparameter patient monitor. SpO2 will be measured using a Siemens Infinity SC7000 multiparameter monitor. This monitor uses Siemens' Oxisure pulse oximetry technology and Nellcor Oximax saturation probes and incorporates ECG to reduce motion artefact. To reduce the influence of artefact further, data from an infants chest leads (recording heart rate) will also be downloaded. If there is a greater than 10 beats per minute difference between heart rate measured from the pulse oximeter and heart rate measured from the chest leads, SpO2 for that time point will be disregarded.
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, with transcutaneous monitoring part of the monitoring equipment we use in selected infants in our unit and being transported by our local neonatal transport team. Temperature is supervised by two independent circuits, as well as by the monitor firmware.
Transcutaneous data will be transferred contemporaneously to a bedside PC via the proprietary software V-STATS (with V-CareNeT) version 4.01. We will ensure the time on the monitor is synchronised with the time displayed on the electronic patient record system recording SpO2 and heart rate. V-STATS software can identify any spurious spikes in TcPO2 caused by air bubbles and these identified segments of data will be discarded. Artefact has not significantly affected readings during the routine use of this monitor previously on our neonatal unit and with our neonatal transport team. The site of the transcutaneous probe will be rotated on each infant every 2 hours.
SpO2, TcPO2 and heart rate data will be recorded every second. The time of any arterial oxygen samples taken routinely during the study will be recorded from the unit Radiometer ABL800 FLEX blood gas analyser.
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 oxygen target ranges in premature infants, with infants acting as their own controls.
| Arm | Type | Receives |
|---|---|---|
| Higher target range | Experimental | Other: Higher target rangeInfants will be targeted to 92-97% oxygen saturation |
| Standard target range | No intervention | –Infants will be targeted to 90-95% oxygen saturation, which is the range used as routine in the Neonatal Unit involved in the study |
Who may qualify
- Ages
- 48 hours to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants born at less than 29 weeks gestation
- Infants greater than 48 hours of age
- Infants who are receiving supplementary oxygen
Key exclusion criteria (1 listed)
- Congenital anomalies that would affect oxygenation (eg. cardiac defects, congenital diaphragmatic hernia)
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 |
|---|---|---|
| Higher target rangeAlso: Using a higher oxygen saturation target rangeIntervention is using a higher oxygen saturation target range than in routine practice | Other | Higher target range |
Primary outcome
Incidence of hyperoxia and hypoxia on saturations
Time frame: 12 hours
Percentage time spent above an SpO2 of 97% and below an SpO2 of 90% when infants are targeted to an SpO2 range of 92-97% compared to 90-95%
6 secondary outcomes
Incidence of hyperoxia and hypoxia on Transcutaneous monitoring
Time frame: 12 hours
Saturation variability
Time frame: 12 hours
Transcutaneous variability
Time frame: 12 hours
Characterise PaO2 values within the two oxygen saturation target ranges
Time frame: 12 hours
Pooled frequency histogram of SpO2
Time frame: 12 hours
Pooled frequency histogram of TcPO2
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 28 Mar 2022.
- Derived from this study: PubMed 37142388Christie FG, Kelly R, Boardman JP, Stenson BJ. Measuring Oxygenation in Newborn Infants with Targeted Oxygen Ranges (MONITOR): a randomised crossover pilot study. Arch Dis Child Fetal Neonatal Ed. 2023 Nov;108(6):638-642. doi: 10.1136/archdischild-2022-324833. Epub 2023 May 4.
- 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 testing Higher target range in people with Premature Infant and Hypoxia, 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 3 inclusion and 1 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 28 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 saturations (time frame: 12 hours). 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 NCT03360292, which also lists 1 linked publication.
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 28 Mar 2022.