Pulse OximetryNCT05994417
Beyond Race: Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants
An observational study of Pulse Oximetry and Disparities, run by Arkansas Children's Hospital Research Institute.
Trial summary
The overall objective of this proposal is to quantify the bias in pulse oximeter reported oxygen saturation (SpO2) by evaluating its measures compared to the gold standard blood gas measured arterial oxygen saturation (SaO2) across race and skin pigmentation. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Pulse Oximetry, Disparities, Infants
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2023to 31 Dec 2025
- Phase
- Observational
- 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 3 months
- All sexes
- No healthy volunteers
- Child
Study population: All preterm (i.e. infant less than 37 weeks gestation) and term infants (i.e. infants >= 37 weeks gestation) that have an indwelling arterial line and are admitted to the ACH neonatal intensive care unit (NICU) and cardiovascular intensive care unit (CVICU).
Who may be able to join
- Signed Informed Consent
- Postnatal age less than 3 months corrected age
- Presence of an in-dwelling umbilical or peripheral arterial line
- Gestational age >= 25 weeks
Who cannot join
- Known skin pigmentary disorders
- Significantly impaired skin integrity
- Systemic bruising due to birth trauma
- Circulatory shock within last 48 hours
- Infants of peri-viable gestation (22-24 weeks)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants
The overall objective of this proposal is to quantify the bias in pulse oximeter reported oxygen saturation (SpO2) by evaluating its measures compared to the gold standard blood gas measured arterial oxygen saturation (SaO2) across race and skin pigmentation. The main question that the investigators intend to answer is whether
- There is greater pulse oximeter bias and subclinical hypoxemia in (1a) Black compared to White infants, and (1b) dark versus light-pigmented infants
- This bias increases with gestational and postnatal maturation
- This bias is associated with adverse patient outcomes
Read the detailed description
The study investigators will conduct a prospective observational study involving 200 infants (0-3 months age) and compare simultaneously obtained pulse oximeter readings (SpO2) and co-oximeter measured blood gas arterial oxygen saturation (SaO2), among infants identified as Non-Hispanic Black and Non-Hispanic White. The investigators will also obtain an objective assessment of skin pigmentation using a non-invasive device, SkinColorCatch® (by Delfin Technologies Ltd, Finland) that provides (1) a melanin index and (2) an objective six-point categorization of skin color based on Individual Typology Angle (ITA). Therefore, the investigators will measure the pulse oximeter bias (SpO2-SaO2) across infants identified as Non-Hispanic Black and Non-Hispanic White, as well as among infants of various skin pigmentation. For infants that have an arterial line for more than one week, the researchers will measure pulse oximeter bias (SpO2-SaO2) on a weekly basis over time with skin maturation and pigmentation changes.
- Conditions
- Pulse Oximetry, Disparities, Infants
- Keywords
- pulse oximeter, bias, disparities, infants, premature
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-Hispanic Black | Infants born to mothers identifying as Non-Hispanic Black | |
| Non-Hispanic White | Infants born to mothers identifying as Non-Hispanic White | |
| Infants across the spectrum of melanin index and ITA-based skin color classification | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systematic Bias in pulse oximetry
The difference between the blood gas measured arterial oxygen saturation (SaO2) and pulse oximeter reported oxygen saturation (SpO2)
Measured: Within 5 seconds
Secondary outcomes (1)
Occult Hypoxemia
The prevalence of occult hypoxemia defined as pulse oximeter reported oxygen saturation (SpO2) of greater than 90% when blood gas measured arterial oxygen saturation (SaO2) is less than 88%.
Measured: Within 5 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start15 Aug 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulse OximetryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megha Sharma, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994417
- Sponsor's protocol ID
- 275653
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants
- ClinicalTrials.gov ID
- NCT05994417
- Acronym / sponsor ID
- 275653
- Conditions
- Pulse Oximetry, Disparities, Infants
- Keywords
- pulse oximeter, bias, disparities, infants, premature
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 15 Aug 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Aug 2023 (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 overall objective of this proposal is to quantify the bias in pulse oximeter reported oxygen saturation (SpO2) by evaluating its measures compared to the gold standard blood gas measured arterial oxygen saturation (SaO2) across race and skin pigmentation. The main question that the investigators intend to answer is whether
- There is greater pulse oximeter bias and subclinical hypoxemia in (1a) Black compared to White infants, and (1b) dark versus light-pigmented infants
- This bias increases with gestational and postnatal maturation
- This bias is associated with adverse patient outcomes
Detailed description
The study investigators will conduct a prospective observational study involving 200 infants (0-3 months age) and compare simultaneously obtained pulse oximeter readings (SpO2) and co-oximeter measured blood gas arterial oxygen saturation (SaO2), among infants identified as Non-Hispanic Black and Non-Hispanic White. The investigators will also obtain an objective assessment of skin pigmentation using a non-invasive device, SkinColorCatch® (by Delfin Technologies Ltd, Finland) that provides (1) a melanin index and (2) an objective six-point categorization of skin color based on Individual Typology Angle (ITA). Therefore, the investigators will measure the pulse oximeter bias (SpO2-SaO2) across infants identified as Non-Hispanic Black and Non-Hispanic White, as well as among infants of various skin pigmentation. For infants that have an arterial line for more than one week, the researchers will measure pulse oximeter bias (SpO2-SaO2) on a weekly basis over time with skin maturation and pigmentation changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Hispanic Black | – | –Infants born to mothers identifying as Non-Hispanic Black |
| Non-Hispanic White | – | –Infants born to mothers identifying as Non-Hispanic White |
| Infants across the spectrum of melanin index and ITA-based skin color classification | – | – |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All preterm (i.e. infant less than 37 weeks gestation) and term infants (i.e. infants >= 37 weeks gestation) that have an indwelling arterial line and are admitted to the ACH neonatal intensive care unit (NICU) and cardiovascular intensive care unit (CVICU).
Key inclusion criteria (4 listed)
- Signed Informed Consent
- Postnatal age less than 3 months corrected age
- Presence of an in-dwelling umbilical or peripheral arterial line
- Gestational age >= 25 weeks
Key exclusion criteria (5 listed)
- Known skin pigmentary disorders
- Significantly impaired skin integrity
- Systemic bruising due to birth trauma
- Circulatory shock within last 48 hours
- Infants of peri-viable gestation (22-24 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systematic Bias in pulse oximetry
Time frame: Within 5 seconds
The difference between the blood gas measured arterial oxygen saturation (SaO2) and pulse oximeter reported oxygen saturation (SpO2)
1 secondary outcome
Occult Hypoxemia
Time frame: Within 5 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulse Oximetry and Disparities, run by Arkansas Children's Hospital Research Institute.
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 5 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: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Megha Sharma, MD MS (501-364-1028, msharma@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systematic Bias in pulse oximetry (time frame: Within 5 seconds). 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 16 Aug 2023.