Verification of Pulse Oximetry in Neonatal Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this his post-market, observational study titled Verification of Pulse Oximetry in the Neonatal Population is to gather data to further support the accuracy of Nonin's pulse oximeters when used in the neonate population. Neonates who are currently undergoing arterial blood gas (ABG) sampling, as part of their medical care will be recruited to participate in this study for collecting opportunity samples. Nonin's PureLight® noninvasive sensor will be applied to a foot of the neonate; an adhesive wrap secures the sensor to the neonate. The sensor immediately begins obtaining SpO2 and pulse rate measurements which are sent to the oximeter module for display on the Electronic Data Collection System (EDCS). At the time the prescribed ABG is drawn, the EDCS must have a marker captured to identify the end of the ABG for SpO2 comparison. The SpO2 accuracy of pulse oximeter will be measured by comparing SpO2 readings of the pulse oximeter to values of SaO2 (opportunity samples) determined by a CO-oximeter.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates

NCT01253772

Hypoxia

COMPLETED

Pulse Oximetry Performance Comparison in Newborns

NCT06637917

Newborn Birth, Preterm

ACTIVE_NOT_RECRUITING

SpO2 Accuracy In Vivo Testing for Neonates & Infants

NCT03843489

Pulse Oximetry

WITHDRAWN NA

Oxygen Saturation Alarms in the Neonatal Intensive Care Unit

NCT01085539

Hypoxemia

COMPLETED

SpO2 Accuracy in Children

NCT07168798

Hypoxemia

ENROLLING_BY_INVITATION

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Distress Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Gestational age: 25 weeks to full term
* Weight range: No minimum or maximum range
* Age: up to 1 month (30 DAYS)
* Gender: Both
* ABGs as part of their medical care, to be analyzed by co-oximeter
* Consent signed by at least one legal guardian

Exclusion Criteria

* Presence of any skin irritation or breakdown on the foot
* Foot impediments which would preclude proper placement of the sensor
* Clinical condition precluding the use of adhesive materials
* Cessation of ABGs during study enrollment

Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No