Beyond Race: Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants

NCT ID: NCT05994417

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2025-12-31

Brief 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. The main question that the investigators intend to answer is whether

1. There is greater pulse oximeter bias and subclinical hypoxemia in (1a) Black compared to White infants, and (1b) dark versus light-pigmented infants

2. This bias increases with gestational and postnatal maturation

3. 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.

Conditions

Pulse Oximetry; Disparities; Infants

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-Hispanic Black

Infants born to mothers identifying as Non-Hispanic Black

No interventions assigned to this group

Non-Hispanic White

Infants born to mothers identifying as Non-Hispanic White

No interventions assigned to this group

Infants across the spectrum of melanin index and ITA-based skin color classification

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Megha Sharma

Assistant Professor, Section of Neonatology, Department of Pediatrics, University of Arkansas for Medical Sciences, Arkansas Children's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Megha Sharma, MD MS

Role: CONTACT

msharma@uams.edu

501-364-1028

Dannis Armikarina, BSN, RN

Role: CONTACT

ArmikarinaDL@archildrens.org

501-296-1389

Other Identifiers

275653

Identifier Type: -

Identifier Source: org_study_id