Pulse Oximetry Clinical Trial
— Neo-PODSOfficial title:
Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation
NCT number | NCT06063148 |
Other study ID # | 1840688 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2022 |
Est. completion date | December 2024 |
Verified date | August 2023 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 163 |
Est. completion date | December 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 10 Days |
Eligibility | Inclusion Criteria: - Newborns postnatal age < 10 days admitted to intensive care unit - Presence of arterial catheter or undergoing arterial stick blood gas sampling Exclusion Criteria: - Presence of abnormal hemoglobin (including methemoglobin > 3%) - likely to only be known after enrolled and the blood gas is obtained - Those in whom SpO2 cannot be measured in the same extremity as the arterial catheter. |
Country | Name | City | State |
---|---|---|---|
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | UC Davis Health | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine if SaO2-SpO2 discrepancy varies with the degree of skin pigmentation among neonates. | Using a prospective cohort of 163 newborns, the investigators will calculate simultaneous SaO2-SpO2 discrepancy and correlate it with a measure of skin pigmentation (melanin index) among neonates with and without hypoxemia. | Through study completion, about 2 years | |
Primary | Determine the influence of gestational age on SaO2-SpO2 discrepancy in newborns with various degrees of light and dark skin. | Premature infants have thinner skin compared to term infants. In this cohort, the investigators will test the hypothesis that SaO2-SpO2 discrepancy increases with gestational age particularly in infants with dark skin. The investigators will calculate the SaO2-SpO2 discrepancy and correlate it with gestational age of infants. | Through study completion, about 2 years | |
Primary | Determine the influence of packed red blood cell (PRBC) transfusion on SaO2-SpO2 discrepancy in newborns with various degrees of light and dark skin. | Many infants in the NICU setting are transfused PRBC with hemoglobin A, which shifts the oxygen-hemoglobin dissociation curve to the right. While the effect of this shift on pulse oximetry is studied, the combined impact of skin pigmentation and transfusion is not known. The investigators will test the hypothesis that PRBC transfusion increases the impact of skin pigmentation on SaO2- SpO2 discrepancy. The investigators will calculate the SaO2-SpO2 discrepancy and correlate it with the skin pigmentation measurement and frequency of PRBC transfusion. | Through study completion, about 2 years |
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