Hypoxia NeonatalNCT05635513
Owlet Smart Sock 3 Accuracy on Infants
An observational study of Hypoxia Neonatal, run by Owlet Baby Care, Inc. at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the Owlet Smart Sock 3 wireless pulse oximeter performance in assessing the heart rate and oxygen saturation in neonatal population, while measuring the same parameter with a standard wired pulse oximeter simultaneously. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypoxia Neonatal
- What is being tested?
- Owlet OSS V3
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2021to 3 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants admitted to the University of Utah NICU that weigh between 1.7kg and 2.3kg and do not meet exclusion criteria.
Who may be able to join
- Infant who weigh between 1.7kg and 2.3kg
- Infant who is admitted to U of U NICU
Who cannot join
- Infant who has injuries, deformities, abnormalities, or intravenous catheter in the extremities that may prevent proper application of device
- Infant who has unstable vital signs or clinical condition
- No parental consent
- Inability to achieve adequate fit with the OSS3
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to evaluate the Owlet Smart Sock 3 wireless pulse oximeter performance in assessing the heart rate and oxygen saturation in neonatal population, while measuring the same parameter with a standard wired pulse oximeter simultaneously. The monitoring duration with the study device will be a maximum of 60 minutes, after which the recorded data from the Owlet Smart Sock 3 and the standard wired pulse oximeters will be de-identified and analyzed.
Read the detailed description
This prospective observational study compared the HR and SpO2 measurements of the OSS3 (Owlet, Utah, USA) with the Masimo SET® (Masimo Corporation, California, USA) in infants admitted to the University of Utah NICU. The inclusion criteria were infants who weighed 1.7-2.5 kg at the time of monitoring and were medically stable to tolerate routine care. The exclusion criteria were: infants with significant anomalies, congenital deformities, or medical instability. Infants with an intravenous catheter (IV) and skin lesions on either foot were excluded from the study. The wireless device being tested was the OSS3. The gold standard for validating the pulse oximeter's accuracy is arterial blood oxygen saturation (SaO 2 ) at the pulse oximeter sensor site. [6] However, obtaining SaO2 is an invasive arterial blood test for infants. To avoid this conflict, the OSS3 was tested against the reference FDA-approved wired pulse oximeter Masimo.
The study was approved by the University of Utah Institutional Review Board, and informed consent was obtained from parents. During the measurement, OSS3 and Masimo were placed on the infants with one device on each foot. Since the data obtained from the study devices can not be recorded in the hospital electronic medical record, the hospital wired pulse oximeter (Philips, Amsterdam, Netherlands) continued to be used on one of the infant's hands during the study period. OSS3 and Masimo were calibrated appropriately against the hospital wired pulse oximeter with matching HR and SpO 2 readings. Pulse oximetry data were collected simultaneously for 60 minutes on the quiet infants. The two devices (OSS3 and Masimo) continuously recorded HR (beats per minute, bpm) and SpO2 (%) every two seconds. Data from the 2 devices were uploaded and compared according to their time stamped measurements. The paired data agreement was compared using Pearson's correlation coefficient (r), Bland-Altman, Average Root Mean Square (ARMS), and Prevalence and Bias Adjusted Kappa (PABAK) analyses.
- Conditions
- Hypoxia Neonatal
- Being tested
- Owlet OSS V3
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Owlet OSS V3Device
A wearable pulse oximeter designed for monitoring infants and children in a home environment
What is being measured
The primary outcome is the main question the study is designed to answer.
Owlet Oxygen Saturation Accuracy Performance
Conduct a single-arm observational study to monitor oxygen saturation (SpO2) while a standard wired pulse oximeter (WPOx) will simultaneously evaluate the same parameters in the University of Utah (U of U) Neonatal Intensive Care Unit (NICU).
Measured: During the monitoring period (approx. 1 hour)
Owlet Pulse Rate Accuracy Performance
Conduct a single-arm observational study to monitor heart rate (HR), while a standard wired pulse oximeter (WPOx) will simultaneously evaluate the same parameters in the University of Utah (U of U) Neonatal Intensive Care Unit (NICU).
Measured: During the monitoring period (approx. 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start14 Jul 2021
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Owlet Baby Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Belinda Chan, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635513
- Sponsor's protocol ID
- OWL NICU 07-2021
- Status last verified
- Dec 2022
- First submitted
- 22 Nov 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Owlet Smart Sock 3 Accuracy on Infants
- ClinicalTrials.gov ID
- NCT05635513
- Acronym / sponsor ID
- OWL NICU 07-2021
- Conditions
- Hypoxia Neonatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Owlet Baby Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the Owlet Smart Sock 3 wireless pulse oximeter performance in assessing the heart rate and oxygen saturation in neonatal population, while measuring the same parameter with a standard wired pulse oximeter simultaneously. The monitoring duration with the study device will be a maximum of 60 minutes, after which the recorded data from the Owlet Smart Sock 3 and the standard wired pulse oximeters will be de-identified and analyzed.
Detailed description
This prospective observational study compared the HR and SpO2 measurements of the OSS3 (Owlet, Utah, USA) with the Masimo SET® (Masimo Corporation, California, USA) in infants admitted to the University of Utah NICU. The inclusion criteria were infants who weighed 1.7-2.5 kg at the time of monitoring and were medically stable to tolerate routine care. The exclusion criteria were: infants with significant anomalies, congenital deformities, or medical instability. Infants with an intravenous catheter (IV) and skin lesions on either foot were excluded from the study. The wireless device being tested was the OSS3. The gold standard for validating the pulse oximeter's accuracy is arterial blood oxygen saturation (SaO 2 ) at the pulse oximeter sensor site. [6] However, obtaining SaO2 is an invasive arterial blood test for infants. To avoid this conflict, the OSS3 was tested against the reference FDA-approved wired pulse oximeter Masimo.
The study was approved by the University of Utah Institutional Review Board, and informed consent was obtained from parents. During the measurement, OSS3 and Masimo were placed on the infants with one device on each foot. Since the data obtained from the study devices can not be recorded in the hospital electronic medical record, the hospital wired pulse oximeter (Philips, Amsterdam, Netherlands) continued to be used on one of the infant's hands during the study period. OSS3 and Masimo were calibrated appropriately against the hospital wired pulse oximeter with matching HR and SpO 2 readings. Pulse oximetry data were collected simultaneously for 60 minutes on the quiet infants. The two devices (OSS3 and Masimo) continuously recorded HR (beats per minute, bpm) and SpO2 (%) every two seconds. Data from the 2 devices were uploaded and compared according to their time stamped measurements. The paired data agreement was compared using Pearson's correlation coefficient (r), Bland-Altman, Average Root Mean Square (ARMS), and Prevalence and Bias Adjusted Kappa (PABAK) analyses.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants admitted to the University of Utah NICU that weigh between 1.7kg and 2.3kg and do not meet exclusion criteria.
Key inclusion criteria (2 listed)
- Infant who weigh between 1.7kg and 2.3kg
- Infant who is admitted to U of U NICU
Key exclusion criteria (4 listed)
- Infant who has injuries, deformities, abnormalities, or intravenous catheter in the extremities that may prevent proper application of device
- Infant who has unstable vital signs or clinical condition
- No parental consent
- Inability to achieve adequate fit with the OSS3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Owlet OSS V3A wearable pulse oximeter designed for monitoring infants and children in a home environment | Device | – |
Primary outcome
Owlet Oxygen Saturation Accuracy Performance
Time frame: During the monitoring period (approx. 1 hour)
Conduct a single-arm observational study to monitor oxygen saturation (SpO2) while a standard wired pulse oximeter (WPOx) will simultaneously evaluate the same parameters in the University of Utah (U of U) Neonatal Intensive Care Unit (NICU).
Owlet Pulse Rate Accuracy Performance
Time frame: During the monitoring period (approx. 1 hour)
Conduct a single-arm observational study to monitor heart rate (HR), while a standard wired pulse oximeter (WPOx) will simultaneously evaluate the same parameters in the University of Utah (U of U) Neonatal Intensive Care Unit (NICU).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belinda Chan, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia Neonatal, run by Owlet Baby Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Owlet Oxygen Saturation Accuracy Performance (time frame: During the monitoring period (approx. 1 hour)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.