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NCT06063148 · ClinicalTrials.gov registry record · NA
Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation
A NA study of Pulse Oximetry and Skin Pigment, sponsored by University of California, Davis.
- Active
- Registry status
- NA
- Development phase
- 163
- Enrollment target
- 2
- Study locations
NCT06063148: Active NA study of Pulse Oximetry and Skin Pigment, sponsored by University of California, Davis.
NCT06063148 is a NA study of Pulse Oximetry and Skin Pigment that is active but no longer recruiting, run by University of California, Davis. The registered enrollment target is 163 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06063148, a NA study of Pulse Oximetry and Skin Pigment, is active but no longer recruiting, sponsored by University of California, Davis.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 163 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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: Fitzpatrick Scale, Massey-Martin scale and ITA: individual Typology Angle) among neonates with and without hypoxemia.
Conditions Studied
Interventions
- DEVICE Enrolled Participant
Study Locations (2)
California
- UC Davis Health - Sacramento
Mississippi
- University of Mississippi Medical Center - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2026-04 |
| Phase | NA |
What the registry record for NCT06063148 still lists
NCT06063148 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Pulse Oximetry appearing as the primary indexed condition, and to 1 intervention - of which Enrolled Participant is the first listed.
NCT06063148 reports a single indexed study location in California, Mississippi.
Frequently Asked Questions
What is clinical trial NCT06063148 about?
NCT06063148 is a clinical study titled "Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation". 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 th...
What is the current status of trial NCT06063148?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 163 participants. The study started on 2022-04-01. Estimated completion is 2026-04.
What conditions does trial NCT06063148 study?
This clinical trial studies the following conditions: Pulse Oximetry, Skin Pigment.
What interventions are being tested in trial NCT06063148?
The interventions under investigation include: Enrolled Participant (DEVICE).
Who is sponsoring clinical trial NCT06063148?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06063148 being conducted?
This trial has 2 study locations across California, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06063148's enrollment target sits among peer trials
163 627th of 2000 higher than 1,374 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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