ACTIVE_NOT_RECRUITING

Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to determine if pulse oximeters show an SaO2-SpO2 discrepancy that correlates with skin pigmentation such that pulse oximetry will overestimate oxygenation in newborns with darker skin. The main questions it aims to answer is if SaO2-SpO2 discrepancy varies with the degree of skin pigmentation among neonates, if gestational age has an influence on SaO2-SpO2 discrepancy, and if packed red blood cell (PRBC) transfusion has an influence on SaO2-SpO2 discrepancy in newborns with various degrees of light and dark skin. Researchers will compare SaO2 and SpO2 values in neonates of various skin pigmentation.

Official Title

Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation

Quick Facts

Study Start:2022-04-01
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06063148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 10 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Newborns postnatal age \< 10 days admitted to intensive care unit
  2. * Presence of arterial catheter or undergoing arterial stick blood gas sampling
  1. * \<26 weeks corrected gestational age (After May 2024, infants \<26 weeks corrected GA were excluded due to skin irritation with sensor removal, those enrolled earlier were included in the analysis)
  2. * Presence of abnormal hemoglobin (including methemoglobin \> 3%) - likely to only be known after enrolled and the blood gas is obtained
  3. * Those in whom SpO2 cannot be measured in the same extremity as the arterial catheter.

Contacts and Locations

Study Locations (Sites)

UC Davis Health
Sacramento, California, 95817
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States

Collaborators and Investigators

Sponsor: University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-01
Study Completion Date2026-01

Study Record Updates

Study Start Date2022-04-01
Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

  • Skin Pigment
  • Pulse Oximetry