Neonatal DiseaseAg-OSNCT05065229
A Study of Agreement Between Oxygen Saturation Measured by Two Probes in Infants on the Neonatal Unit
A study testing Oxygen saturation probe Mindray 520 N and Mindray 521 N in people with Neonatal Disease, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
On the neonatal unit in Derby, two types of probes are in routine use: Mindray 520 N and Mindray 521 N. Feedback from parents and staff show that there are concerns that the two probes given very different oxygen saturation readings and, often, do not agree with each other. Read more about this study
- Who is it for?
- Ages 32 to 60 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal Disease
- What is being tested?
- Oxygen saturation probe Mindray 520 N and Mindray 521 N
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jul 2021to 14 Jan 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 32 to 60 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants who need oxygen saturation monitoring for clinical care
- Infants born preterm (<37 weeks' gestation) who are < 7 days of age and need respiratory support including supplemental oxygen
- Infants born preterm (<37 weeks' gestation) who are in supplemental oxygen at >34 weeks' gestation
- Infants born at term gestation (< 37 weeks' gestation) who require respiratory support including supplemental oxygen
- Infants with suspected cardiac disease
Who cannot join
- Infants who have intravenous or arterial lines attached to either foot.
- Infants who have any condition that may cause differential oxygen saturation or blood flow to the lower limbs such as venous thrombosis.
- Infants who have local infections or skin lesions on either foot.
- Infants older than 5 months of age
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Derby and Burton
Derby, Derbyshire, DE3 0ED
About this study
On the neonatal unit in Derby, two types of probes are in routine use: Mindray 520 N and Mindray 521 N. Feedback from parents and staff show that there are concerns that the two probes given very different oxygen saturation readings and, often, do not agree with each other. This has raised concerns that infants' clinical care may be affected by the choice of probe. It is important to know if the two probes give similar results or not to ensure that infants get the appropriate monitoring and respiratory support as needed for good neonatal care. In this study, we will compare the reading made by the two probes and determine whether the readings of the two probes agree with each other and if any disagreement is such that clinical decision making is affected by the difference.
Read the detailed description
Continuous monitoring of oxygen saturation level is a key component of neonatal intensive care and NICE recommends that all neonatal services "ensure that systems are in place for preterm babies to have a target saturation level of 91% to 95%" and that this is monitored using "continuous pulse oximetry" (NICE Quality statement 4 in Quality Standard QS193: https://www.nice.org.uk/guidance/qs193/chapter/Quality-statement-4-Oxygen-saturation). Oxygen saturation monitoring is used to provide optimal respiratory support to preterm infants to ensure adequate oxygenation of tissues while preventing risks of conditions such as retinopathy of prematurity and bronchopulmonary dysplasia [1]. It is equally important in term born infants who require intensive care such as for determining adequate oxygenation for respiratory support and screening for congenital heart disease [2]. For these reasons, most infants in neonatal units are continuously monitored using pulse oximetry, a simple and painless test that measures blood oxygen levels by passing a small beam of light through the infant's hand or foot. This measures the changes in light absorption to calculate the levels of oxygenated and deoxygenated blood. To do this the light (or probe) has to be attached to the infant's hand or foot using a tie or a sticker. The probe must be attached firmly for the saturation monitor to pick up the correct readings. As neonatal skin is delicate and it is often difficult to stick objects to it, neonatal oxygen saturation probes are carefully designed. Many different types of saturation probes are in routine use in neonatal units. It is important to ensure that they give accurate and comparable readings. In the neonatal unit in Derby, two types of probes are in routine use: Mindray 520 N and Mindray 521 N. Feedback from parents and staff show that there are concerns that the two probes given very different oxygen saturation readings and, often, do not agree with each other. This has raised concerns that infants' clinical care may be affected by the choice of probe. It is important to know if the two probes give similar results or not to ensure that infants get the appropriate monitoring and respiratory support as needed for good neonatal care. In this study, we will compare the reading made by the two probes and determine whether the readings of the two probes agree with each other and if any disagreement is such that clinical decision making is affected by the difference.
- Conditions
- Neonatal Disease
- Being tested
- Oxygen saturation probe Mindray 520 N and Mindray 521 N
- 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.
Oxygen saturation probe Mindray 520 N and Mindray 521 NDevice
Two oxygen saturation probes will be used in this study:
Mindray 520 N is a disposable oxygen saturation sensor for neonates and adults. It is a disposable, single-use sensor that is wrapped around the infant's arm or foot. Its ends stick together giving a firm, close contact with the skin.
Mindray 521 N is another disposable oxygen saturation sensor for neonates and adults that is used on the neonatal unit in routine practice. As Mindray 520 N and 521 N are CE marked and used within their intended purposes we do not require a letter of no objection from the MHRA for that usage. The Mindray probes will be used without modification and there are no safety issues to the patient. Therefore, a letter of no objection from the MHRA is not required and this is not a medical device study under the Medical Devices Directive.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Right foot no.520 Left foot no.521 Receives: Device: Oxygen saturation probe Mindray 520 N and Mindray 521 N |
| B | Experimental | Right foot no.521 Left foot no.520 Receives: Device: Oxygen saturation probe Mindray 520 N and Mindray 521 N |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen saturation of babies using Minday 520 N and Minday 521 N
Oxygen saturation readings using Minday 520 N and Minday 521 N probes simultaneously
Measured: 12 months
Secondary outcomes (1)
clinical decision making
clinical decisions made, such as giving supplemental oxygen to infants on the neonatal unit following oxygen saturation readings from Minday 520 N and Mindray 521 N
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start15 Jul 2021
- Primary completion11 Jan 2023
- Study completion14 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DiseaseStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group, randomised study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- shalini ojha, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065229
- Sponsor's protocol ID
- IRAS 297715
- Acronym
- Ag-OS
- Status last verified
- Sep 2023
- First submitted
- 4 Aug 2021
- Last updated
- 8 Sep 2023
- 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 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Agreement Between Oxygen Saturation Measured by Two Probes in Infants on the Neonatal Unit
- ClinicalTrials.gov ID
- NCT05065229
- Acronym / sponsor ID
- Ag-OS / IRAS 297715
- Conditions
- Neonatal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 14 Jan 2023 (actual)
- First posted
- 4 Oct 2021 (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.
On the neonatal unit in Derby, two types of probes are in routine use: Mindray 520 N and Mindray 521 N. Feedback from parents and staff show that there are concerns that the two probes given very different oxygen saturation readings and, often, do not agree with each other. This has raised concerns that infants' clinical care may be affected by the choice of probe. It is important to know if the two probes give similar results or not to ensure that infants get the appropriate monitoring and respiratory support as needed for good neonatal care. In this study, we will compare the reading made by the two probes and determine whether the readings of the two probes agree with each other and if any disagreement is such that clinical decision making is affected by the difference.
Detailed description
Continuous monitoring of oxygen saturation level is a key component of neonatal intensive care and NICE recommends that all neonatal services "ensure that systems are in place for preterm babies to have a target saturation level of 91% to 95%" and that this is monitored using "continuous pulse oximetry" (NICE Quality statement 4 in Quality Standard QS193: https://www.nice.org.uk/guidance/qs193/chapter/Quality-statement-4-Oxygen-saturation). Oxygen saturation monitoring is used to provide optimal respiratory support to preterm infants to ensure adequate oxygenation of tissues while preventing risks of conditions such as retinopathy of prematurity and bronchopulmonary dysplasia [1]. It is equally important in term born infants who require intensive care such as for determining adequate oxygenation for respiratory support and screening for congenital heart disease [2]. For these reasons, most infants in neonatal units are continuously monitored using pulse oximetry, a simple and painless test that measures blood oxygen levels by passing a small beam of light through the infant's hand or foot. This measures the changes in light absorption to calculate the levels of oxygenated and deoxygenated blood. To do this the light (or probe) has to be attached to the infant's hand or foot using a tie or a sticker. The probe must be attached firmly for the saturation monitor to pick up the correct readings. As neonatal skin is delicate and it is often difficult to stick objects to it, neonatal oxygen saturation probes are carefully designed. Many different types of saturation probes are in routine use in neonatal units. It is important to ensure that they give accurate and comparable readings. In the neonatal unit in Derby, two types of probes are in routine use: Mindray 520 N and Mindray 521 N. Feedback from parents and staff show that there are concerns that the two probes given very different oxygen saturation readings and, often, do not agree with each other. This has raised concerns that infants' clinical care may be affected by the choice of probe. It is important to know if the two probes give similar results or not to ensure that infants get the appropriate monitoring and respiratory support as needed for good neonatal care. In this study, we will compare the reading made by the two probes and determine whether the readings of the two probes agree with each other and if any disagreement is such that clinical decision making is affected by the difference.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group, randomised study
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Oxygen saturation probe Mindray 520 N and Mindray 521 NRight foot no.520 Left foot no.521 |
| B | Experimental | Device: Oxygen saturation probe Mindray 520 N and Mindray 521 NRight foot no.521 Left foot no.520 |
Who may qualify
- Ages
- 32 to 60 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants who need oxygen saturation monitoring for clinical care
- Infants born preterm (<37 weeks' gestation) who are < 7 days of age and need respiratory support including supplemental oxygen
- Infants born preterm (<37 weeks' gestation) who are in supplemental oxygen at >34 weeks' gestation
- Infants born at term gestation (< 37 weeks' gestation) who require respiratory support including supplemental oxygen
- Infants with suspected cardiac disease
Key exclusion criteria (4 listed)
- Infants who have intravenous or arterial lines attached to either foot.
- Infants who have any condition that may cause differential oxygen saturation or blood flow to the lower limbs such as venous thrombosis.
- Infants who have local infections or skin lesions on either foot.
- Infants older than 5 months of age
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 |
|---|---|---|
| Oxygen saturation probe Mindray 520 N and Mindray 521 NTwo oxygen saturation probes will be used in this study: Mindray 520 N is a disposable oxygen saturation sensor for neonates and adults. It is a disposable, single-use sensor that is wrapped around the infant's arm or foot. Its ends stick together giving a firm, close contact with the skin. Mindray 521 N is another disposable oxygen saturation sensor for neonates and adults that is used on the neonatal unit in routine practice. As Mindray 520 N and 521 N are CE marked and used within their intended purposes we do not require a letter of no objection from the MHRA for that usage. The Mindray probes will be used without modification and there are no safety issues to the patient. Therefore, a letter of no objection from the MHRA is not required and this is not a medical device study under the Medical Devices Directive. | Device | A, B |
Primary outcome
oxygen saturation of babies using Minday 520 N and Minday 521 N
Time frame: 12 months
Oxygen saturation readings using Minday 520 N and Minday 521 N probes simultaneously
1 secondary outcome
clinical decision making
Time frame: 12 months
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 8 Sep 2023.
- 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.
shalini ojha principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen saturation probe Mindray 520 N and Mindray 521 N in people with Neonatal Disease, run by University of Nottingham 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 5 inclusion and 4 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 8 Sep 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 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?
oxygen saturation of babies using Minday 520 N and Minday 521 N (time frame: 12 months). 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 8 Sep 2023.