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Pulse Oximeter Sensors

Pulse Oximetry for Newborn Oxygen Monitoring

N/A
Recruiting
Research Sponsored by Medline Industries
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 15 episodic minutes at the time of the blood draw
Awards & highlights

Study Summary

This trial compares the accuracy of a pulse oximeter to measure oxygen levels in the blood of newborns to a more invasive and expensive method.

Who is the study for?
This trial is for newborns who are 28 days old or younger, weigh under 5 Kg, and are expected to have arterial blood gas tests as part of their standard care. Newborns with significant heart issues (PDA), physical malformations that prevent sensor placement, skin allergies to sensor materials, or deemed unsuitable by the lead researcher cannot participate.Check my eligibility
What is being tested?
The study aims to check if Medline's reprocessed pulse oximetry sensors accurately measure oxygen levels in the blood of premature babies. This will be compared against direct measurements from a CO-oximeter using arterial blood samples.See study design
What are the potential side effects?
There may not be any direct side effects from participating in this trial since it involves non-invasive monitoring with pulse oximetry sensors. However, there could be potential risks related to skin irritation due to adhesive tapes or foam rubber used in the sensors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 15 episodic minutes at the time of the blood draw
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 15 episodic minutes at the time of the blood draw for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pulse oximeter and co-oximeter readings

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pulse oximeter sensor readingsExperimental Treatment1 Intervention
Subjects who satisfy all of the inclusion criteria will be eligible to participate in the study, will receive intervention (the Masimo and Nellcor sensors, and their arterial blood sample will be taken in the normal course of care). This is a single arm study. Those who don't meet the inclusion/ exclusion criteria won't be eligible to participate.

Find a Location

Who is running the clinical trial?

Medline IndustriesLead Sponsor
45 Previous Clinical Trials
23,014 Total Patients Enrolled

Media Library

Pulse oximeter sensors (Pulse Oximeter Sensors) Clinical Trial Eligibility Overview. Trial Name: NCT05250102 — N/A
Premature Birth Research Study Groups: Pulse oximeter sensor readings
Premature Birth Clinical Trial 2023: Pulse oximeter sensors Highlights & Side Effects. Trial Name: NCT05250102 — N/A
Pulse oximeter sensors (Pulse Oximeter Sensors) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05250102 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment available for this experiment at present?

"According to the clinicaltrials.gov listing, this study is no longer seeking volunteers and has not been updated since May 3rd 2022. Nonetheless, there are still 261 other trials that need participants at present."

Answered by AI

Is this research open to minors?

"This trial has specific eligibility requirements that stipulate participants must only be between one day and four weeks old. Accordingly, there are 184 studies for minors and 74 for seniors."

Answered by AI

Who is eligible for participation in this research trial?

"This clinical trial is seeking 80 applicants who were born prematurely between 1 day and 28 days. To be accepted, candidates must meet this criteria."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Neonatal Pulse Oximetry Sensor Study
2022. "Neonatal Pulse Oximetry Sensor Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05250102.
~10 spots leftby Apr 2025
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