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Neonatal Pulse Oximetry Sensor Study - Trial NCT05250102

Access comprehensive clinical trial information for NCT05250102 through Pure Global AI's free database. This phase not specified trial is sponsored by Medline Industries and is currently Recruiting. The study focuses on Premature Birth. Target enrollment is 27 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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Trial Details
ClinicalTrials.gov โ€ข NCT05250102
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Neonatal Pulse Oximetry Sensor Study
Accuracy and Precision of Peripheral Capillary Oxygen Saturation of Reprocessed Pulse Oximetry Sensors Compared to Oxygen Saturation in Arterial Blood Samples Assessed by CO-oximetry in Neonates

Study Focus

Premature Birth

Pulse oximeter sensors

Interventional

device

Sponsor & Location

Medline Industries

Los Angeles,Greenville, United States of America

Timeline & Enrollment

N/A

Jun 13, 2022

Dec 31, 2023

27 participants

Primary Outcome

Pulse oximeter and co-oximeter readings

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.

ICD-10 Classifications

Fetus and newborn affected by precipitate delivery
Preterm delivery without spontaneous labour
Disorders related to short gestation and low birth weight, not elsewhere classified
Other preterm infants
Preterm spontaneous labour with preterm delivery

Data Source

ClinicalTrials.gov

NCT05250102

Device Trial