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Neonatal Pulse Oximetry Sensor Study

NCT05250102 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-10-30

Study results available
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Summary

To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.

Conditions

  • Premature Birth

Interventions

DEVICE

Pulse oximeter sensors

Pulse oximeter reading will be compared to CO-oximeter reading.

Sponsors & Collaborators

  • Medline Industries

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2023-10-10
Completion
2023-10-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05250102 on ClinicalTrials.gov