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

Launched by ARKANSAS CHILDREN'S HOSPITAL RESEARCH INSTITUTE · Aug 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well pulse oximeters, which are devices that measure the oxygen levels in the blood, work in critically ill infants of different skin colors. The researchers want to find out if there are differences in the accuracy of these devices based on race and skin pigmentation. They aim to see if Black infants and those with darker skin have less accurate readings compared to White and lighter-skinned infants. Additionally, they will explore if these inaccuracies change as babies grow and if they relate to any health problems.

To participate in the study, infants must be less than three months old and have a specific type of IV line for monitoring. They need to be at least 25 weeks gestational age, meaning they should have been born at least that many weeks into the pregnancy. Infants with certain skin conditions or serious health issues are not eligible. If a baby qualifies, the parents will provide informed consent, which means they agree to let their child participate after understanding what the study entails. This trial is important because it could help improve how healthcare providers use pulse oximeters for infants, potentially leading to better care and outcomes for all babies.

Gender

ALL

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)