Neonatal Pulse Oximetry Sensor Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-13

Study Completion Date

2023-10-10

Brief Summary

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

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.

Related Clinical Trials

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

Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population

NCT06771206

Pulse Oximeter Validation

RECRUITING NA

Evaluation of Pulse Oximetry Sensors in Neonates

NCT00179972

Premature Birth

TERMINATED

Baby Oxygen Saturation Study

NCT03092661

Normative Oxygen Saturation Levels in Infants

UNKNOWN

Transcutaneous Partial Oxygen and Carbon Dioxide Pressures Compared With Blood Gas Values

NCT03060018

Critical Illness

COMPLETED NA

Oxygenation Instability and Maturation of Control of Breathing in Premature Infants

NCT03445689

Infant,Premature

COMPLETED

Detailed Description

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

Pulse oximetry helps in measuring peripheral capillary oxygen saturation (SpO2) continuously and non-invasively, and provides an indirect measurement of arterial oxygenation (SaO2) based on the red and infrared light-absorption characteristics of oxygenated and deoxygenated hemoglobin. Uses of pulse oximetry include detection of hypoxia, avoidance of hyperoxia, titration of fractional inspired oxygen, and enabling weaning from mechanical ventilation. Arterial blood gas (ABG) analysis, such as by the use of CO-oximeter, provides a direct measurement of SaO2. However, ABG analysis requires time, expense, and arterial access. Therefore, this study aims to validate the SpO2 accuracy of pulse oximetry sensors (manufactured by Nellcor and Masimo, and reprocessed by Medline Industries, LP) in neonates as compared to ABG measurements as part of their clinical standard of care (SOC), as assessed by CO-oximetry.

Conditions

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

Premature Birth

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pulse oximeter sensor readings

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.

Group Type OTHER

Pulse oximeter sensors

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pulse oximeter sensors

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

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Subjects who are postnatal 28 days or younger (neonates)
* Subjects who are likely to receive one or more ABG measurements as part of their clinical SOC
* Subjects who weigh less than 5 Kg (weight range for thesensors)

Exclusion Criteria

* Subjects with current signs and symptoms of a clinically significant Patent Ductus Arteriosus (PDA) combined with a current or planned arterial line placement which will affect the validity of the co-oximetry measurement
* Subjects with physical malformation of hands, fingers, feet, or toes that would limit the ability to place sensors for this study
* Subjects judged by the Principal Investigator (PI) to be inappropriate for participation in this study
* Subjects for whom placing a pulse oximeter will cause dermatological issues (e.g. allergic to foam rubber or adhesive tape)

Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No