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Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation (Neo-PODS)

Primary Purpose

Skin Pigment, Pulse Oximetry

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enrolled Participant
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Skin Pigment

Eligibility Criteria

undefined - 10 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UC Davis HealthRecruiting
  • University of Mississippi Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enrolled Participant

Arm Description

During routine arterial blood gas sampling, a coordinator will measure SpO2 from a similar extremity. SpO2 data will be recorded using Masimo Radical-7 oximeters. To minimize ambient light interference or optical cross talk from other SpO2 sensors, all the SpO2 sensors will be fully shielded with cloth wraps provided by Masimo. Each enrolled infant will undergo simultaneous blood gas sampling and SpO2 measurement for each routine blood gas collected. Up to a total of 10 SpO2 measurements will be collected, paired with 10 blood gas samples collected as part of routine care, though We anticipate about 3 paired samples (SaO2 and SpO2) per enrolled infant.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2023
Last Updated
September 25, 2023
Sponsor
University of California, Davis
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT06063148
Brief Title
Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation
Acronym
Neo-PODS
Official Title
Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Investigators will use a multicenter prospective cohort approach to measure SpO2 and SaO2 simultaneously in newborns of varying degrees of light and dark skin. The investigators will enroll 163 newborns of varying degrees of light and dark skin to assess the impact of skin pigmentation on the accuracy of pulse oximetry. Data collection will occur during routine blood samples and will involve simultaneous measurement of oxygen saturation by pulse oximetry and additional data extraction from the EHR. The study consists of 4 main components: (1) Skin pigment classification (2) Race and ethnicity classification (3) SpO2 measurement collection (4) EMR data collection (including newborn screen hemoglobin type assessment and transfusion records). After adjusting for SaO2, the SaO2-SpO2 discrepancy will correlate with skin pigmentation such that pulse oximetry will overestimate oxygenation in newborns with darker skin. The distribution of SaO2-SpO2 discrepancy will have more variance in the newborns with darker skin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Pigment, Pulse Oximetry

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
163 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enrolled Participant
Arm Type
Experimental
Arm Description
During routine arterial blood gas sampling, a coordinator will measure SpO2 from a similar extremity. SpO2 data will be recorded using Masimo Radical-7 oximeters. To minimize ambient light interference or optical cross talk from other SpO2 sensors, all the SpO2 sensors will be fully shielded with cloth wraps provided by Masimo. Each enrolled infant will undergo simultaneous blood gas sampling and SpO2 measurement for each routine blood gas collected. Up to a total of 10 SpO2 measurements will be collected, paired with 10 blood gas samples collected as part of routine care, though We anticipate about 3 paired samples (SaO2 and SpO2) per enrolled infant.
Intervention Type
Device
Intervention Name(s)
Enrolled Participant
Intervention Description
Participant will undergo at most 10 SpO2 measurements paired with at most 10 routine blood gas samples.
Primary Outcome Measure Information:
Title
Determine if SaO2-SpO2 discrepancy varies with the degree of skin pigmentation among neonates.
Description
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.
Time Frame
Through study completion, about 2 years
Title
Determine the influence of gestational age on SaO2-SpO2 discrepancy in newborns with various degrees of light and dark skin.
Description
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.
Time Frame
Through study completion, about 2 years
Title
Determine the influence of packed red blood cell (PRBC) transfusion on SaO2-SpO2 discrepancy in newborns with various degrees of light and dark skin.
Description
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.
Time Frame
Through study completion, about 2 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
UC Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Siefkes, MD, MS
Phone
916-892-0902
Email
hsiefkes@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Harshitha Naidu, BS
Email
htnaidu@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Heather Siefkes, MD, MS
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ira Holla, MD
Phone
916-892-0902
Email
iholla@umc.edu
First Name & Middle Initial & Last Name & Degree
Ira Holla, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation

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