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

NCT05994417 | Unknown

• 1 other identifier: 275653
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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. 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. 2.This bias increases with gestational and postnatal maturation
3. 3.This bias is associated with adverse patient outcomes

Conditions

Pulse Oximetry; Disparities; Infants

Keywords

pulse oximeter; bias; disparities; infants; premature

Outcome Measures

Primary Outcomes (1)

• Systematic Bias in pulse oximetry

  The difference between the blood gas measured arterial oxygen saturation (SaO2) and pulse oximeter reported oxygen saturation (SpO2)

  Within 5 seconds

Secondary Outcomes (1)

• Occult Hypoxemia

  Within 5 seconds

Study Arms (3)

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

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Arterial blood collected for routine clinical analysis of blood gas status

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Megha Sharma, MD MS

CONTACT

501-364-1028; msharma@uams.edu

Dannis Armikarina, BSN, RN

CONTACT

501-296-1389; ArmikarinaDL@archildrens.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Section of Neonatology, Department of Pediatrics, University of Arkansas for Medical Sciences, Arkansas Children's Hospital

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: August 15, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 16, 2023

Record last verified: 2023-08