Skin InjuryNCT05561946
An Observational Study of Skin Reaction in Infants Using the Owlet Sock OSS 3.0
An observational study of Skin Injury, run by Owlet Baby Care, Inc. at 2 sites in United States.
Trial summary
This multi-center, open-label, observational study will evaluate possible skin reactions associated with the wearing of the Owlet OSS 3.0 device continuously (except during sensor charging and excessive motion) up to 24 hours per day in a clinical environment. Read more about this study
- Who is it for?
- Ages 44 weeks to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Skin Injury
- What is being tested?
- Owlet OSS 3.0
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Dec 2021to 24 Aug 2022
- 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 44 weeks to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants admitted for care and estimated to be in the hospital ward/unit, and healthy infants able to stay at a clinical site with study team oversight for at least 48 hours.
Who may be able to join
- Provision of signed and dated informed consent form by the legal guardian
- Stated willingness of the guardian to adhere to study procedures and availability for the duration of the study
- Anticipated to maintain continuity of study procedures under study team oversight for a minimum of 48 hours duration
- Male or female infants aged 1 month (44 weeks corrected gestational age) to 18 months, with weight between 5 and 30 lbs who will be observed in a hospital pediatric department, or other clinical site
Who cannot join
- Medical conditions determined by the study subject's physician or site investigator that would prevent their participation
- Presence of any devices or medical equipment that in the opinion of the investigator would interfere with the function of the Owlet device or preclude completion of the protocol
- Patients on vasoactive medications
- Known allergic reactions to nylon, spandex, elastine or polyester film components of the device that will come into contact with skin
- Local skin disease prohibiting wearing of the device
Trial locations and contacts
2 sites in 1 country.
United States2 sites
TOPAZ Clinical Research
Apopka, Florida, 32703
Louisiana State University Health Shreveport
Shreveport, Louisiana, 71130
About this study
This multi-center, open-label, observational study will evaluate possible skin reactions associated with the wearing of the Owlet OSS 3.0 device continuously (except during sensor charging and excessive motion) up to 24 hours per day in a clinical environment.
Read the detailed description
After an informed consent process, the Owlet OSS 3.0 Sock device will be applied to the foot in accordance with the instructions for use for the device. A research team member, along with any appropriate medical personnel, will perform a baseline examination of the skin to ensure there are no preexisting skin or extremity findings which would interfere with interpretation of subsequent examinations.
A review of the medical record will be performed with the consent process to ensure that vital signs and the cardiorespiratory status of the patient is sufficiently stable for the patient to proceed with study participation. A verbal medical history from the parent may be performed in lieu of a medical record review in healthy subjects.
Subject height and weight, and measurements of the circumference of the subject's ankle and midfoot will be performed at the start of the study and recorded. Sock size will be estimated according to subject weight, per the instructions for use.
The device will be worn by the subject continuously, except during skin assessments, when devices are exchanged, or activities of daily living such as bathing and brief ambulation for toddlers.
A baseline photograph will be taken of the study subject's feet and labeled as right/left, to be kept for reference for future skin exams. Skin examinations will be performed every 4 hours on the foot where the device is placed, including with repositioning. A ±30-minute window on either side of the prescribed time will be acceptable (1 hour total) to comply with the schedule of events.
Repositioning the device to the opposite foot will occur routinely every 8 hours, or sooner if there is evidence of a skin reaction related to device wear. Again, a ±30-minute window on either side of the prescribed time will be acceptable for protocol compliance.
A photograph will be taken of the study subject's feet at baseline prior to application of the Owlet Sock OSS 3.0 device. A photograph of the initial application of the device will also be taken and documented in the study subject's record.
Documentation of the date, time, location, and result of each skin exam will be performed. Photographs of any skin reactions with a severity level of 1-7 will be taken. If any skin reactions are observed, the device will not be placed on the affected foot until the reaction has resolved and returned to baseline. The device will be applied to the unaffected foot while the affected foot reaction resolves. If the skin finding does not resolve within the allowed 8 hour window when the sock must be rotated to the opposite foot, the subject will be withdrawn from study intervention.
- Conditions
- Skin Injury
- Being tested
- Owlet OSS 3.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Owlet OSS 3.0Device
The Owlet OSS 3.0 is worn continuously for a minimum of 48 hours and the skin where the device is worn is monitored for any skin injury/irritation
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized Infants | Hospitalized infants that are planned/scheduled to remain in-house for at least 2 days will wear the sock for a minimum of 48 hours and a maximum of 14 days. Receives: Device: Owlet OSS 3.0 | |
| Healthy Infants | Healthy infants, accompanied by their parent or legal guardian, that are able to stay at a clinical site for 2 days to complete a minimum of 48 hours of monitoring. Receives: Device: Owlet OSS 3.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinically Important Skin Reactions
To estimate the incidence of clinically important skin reactions associated with the Owlet Sock OSS 3.0 when instructions for use are followed.
Measured: From baseline to study completion
Secondary outcomes (3)
Skin reaction resolution
Measure the time intervals for resolution of a skin finding related to wear of the device.
Measured: From onset of observation of skin finding until end of study participation, up to 30 days.
Estimate the proportion of skin reactions that require medical intervention.
Categorical determination for need of medical intervention, and description of what type of treatment applied.
Measured: During period of study monitoring, approximately 14 days.
Estimate the incidence of any skin reactions, overall and by severity level.
Measurement of total number of skin findings of any type related to device wear.
Measured: From initiation of study intervention to end of study intervention, approximately 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start21 Dec 2021
- Primary completion4 Aug 2022
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Skin InjuryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Owlet Baby Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Louisiana State University Health Sciences Center Shreveport, University of Utah, Topaz Clinical Research
- Responsible party
- Sponsor
- Investigators
- Alisa Niksch, MD, Study director, Study Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561946
- Sponsor's protocol ID
- OWL 2021-01
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Health Organization. MHealth: New Horizons for Health through Mobile Technologies (Global Observatory for Ehealth). 1st ed., World Health Organization, 2011.
Dangerfield MI, Ward K, Davidson L, Adamian M. Initial Experience and Usage Patterns With the Owlet Smart Sock Monitor in 47,495 Newborns. Glob Pediatr Health. 2017 Dec 4;4:2333794X17742751. doi: 10.1177/2333794X17742751. eCollection 2017.
PubMed 29230431Panda SS, Panda M, Das RR, Mohanty PK. Pulse oximeter probe-induced toe injury in a neonate: A rare avoidable injury. J Clin Neonatol 2014;3:240
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Skin Reaction in Infants Using the Owlet Sock OSS 3.0
- ClinicalTrials.gov ID
- NCT05561946
- Acronym / sponsor ID
- OWL 2021-01
- Conditions
- Skin Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Owlet Baby Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Louisiana State University Health Sciences Center Shreveport, University of Utah, Topaz Clinical Research
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 30 Sep 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.
This multi-center, open-label, observational study will evaluate possible skin reactions associated with the wearing of the Owlet OSS 3.0 device continuously (except during sensor charging and excessive motion) up to 24 hours per day in a clinical environment.
Detailed description
After an informed consent process, the Owlet OSS 3.0 Sock device will be applied to the foot in accordance with the instructions for use for the device. A research team member, along with any appropriate medical personnel, will perform a baseline examination of the skin to ensure there are no preexisting skin or extremity findings which would interfere with interpretation of subsequent examinations.
A review of the medical record will be performed with the consent process to ensure that vital signs and the cardiorespiratory status of the patient is sufficiently stable for the patient to proceed with study participation. A verbal medical history from the parent may be performed in lieu of a medical record review in healthy subjects.
Subject height and weight, and measurements of the circumference of the subject's ankle and midfoot will be performed at the start of the study and recorded. Sock size will be estimated according to subject weight, per the instructions for use.
The device will be worn by the subject continuously, except during skin assessments, when devices are exchanged, or activities of daily living such as bathing and brief ambulation for toddlers.
A baseline photograph will be taken of the study subject's feet and labeled as right/left, to be kept for reference for future skin exams. Skin examinations will be performed every 4 hours on the foot where the device is placed, including with repositioning. A ±30-minute window on either side of the prescribed time will be acceptable (1 hour total) to comply with the schedule of events.
Repositioning the device to the opposite foot will occur routinely every 8 hours, or sooner if there is evidence of a skin reaction related to device wear. Again, a ±30-minute window on either side of the prescribed time will be acceptable for protocol compliance.
A photograph will be taken of the study subject's feet at baseline prior to application of the Owlet Sock OSS 3.0 device. A photograph of the initial application of the device will also be taken and documented in the study subject's record.
Documentation of the date, time, location, and result of each skin exam will be performed. Photographs of any skin reactions with a severity level of 1-7 will be taken. If any skin reactions are observed, the device will not be placed on the affected foot until the reaction has resolved and returned to baseline. The device will be applied to the unaffected foot while the affected foot reaction resolves. If the skin finding does not resolve within the allowed 8 hour window when the sock must be rotated to the opposite foot, the subject will be withdrawn from study intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Infants | – | Device: Owlet OSS 3.0Hospitalized infants that are planned/scheduled to remain in-house for at least 2 days will wear the sock for a minimum of 48 hours and a maximum of 14 days. |
| Healthy Infants | – | Device: Owlet OSS 3.0Healthy infants, accompanied by their parent or legal guardian, that are able to stay at a clinical site for 2 days to complete a minimum of 48 hours of monitoring. |
Who may qualify
- Ages
- 44 weeks to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants admitted for care and estimated to be in the hospital ward/unit, and healthy infants able to stay at a clinical site with study team oversight for at least 48 hours.
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form by the legal guardian
- Stated willingness of the guardian to adhere to study procedures and availability for the duration of the study
- Anticipated to maintain continuity of study procedures under study team oversight for a minimum of 48 hours duration
- Male or female infants aged 1 month (44 weeks corrected gestational age) to 18 months, with weight between 5 and 30 lbs who will be observed in a hospital pediatric department, or other clinical site
Key exclusion criteria (5 listed)
- Medical conditions determined by the study subject's physician or site investigator that would prevent their participation
- Presence of any devices or medical equipment that in the opinion of the investigator would interfere with the function of the Owlet device or preclude completion of the protocol
- Patients on vasoactive medications
- Known allergic reactions to nylon, spandex, elastine or polyester film components of the device that will come into contact with skin
- Local skin disease prohibiting wearing of the device
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 3.0The Owlet OSS 3.0 is worn continuously for a minimum of 48 hours and the skin where the device is worn is monitored for any skin injury/irritation | Device | Healthy Infants, Hospitalized Infants |
Primary outcome
Incidence of Clinically Important Skin Reactions
Time frame: From baseline to study completion
To estimate the incidence of clinically important skin reactions associated with the Owlet Sock OSS 3.0 when instructions for use are followed.
3 secondary outcomes
Skin reaction resolution
Time frame: From onset of observation of skin finding until end of study participation, up to 30 days.
Estimate the proportion of skin reactions that require medical intervention.
Time frame: During period of study monitoring, approximately 14 days.
Estimate the incidence of any skin reactions, overall and by severity level.
Time frame: From initiation of study intervention to end of study intervention, approximately 14 days.
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 30 Sep 2022.
- BackgroundWorld Health Organization. MHealth: New Horizons for Health through Mobile Technologies (Global Observatory for Ehealth). 1st ed., World Health Organization, 2011.
- Background: PubMed 29230431Dangerfield MI, Ward K, Davidson L, Adamian M. Initial Experience and Usage Patterns With the Owlet Smart Sock Monitor in 47,495 Newborns. Glob Pediatr Health. 2017 Dec 4;4:2333794X17742751. doi: 10.1177/2333794X17742751. eCollection 2017.
- BackgroundPanda SS, Panda M, Das RR, Mohanty PK. Pulse oximeter probe-induced toe injury in a neonate: A rare avoidable injury. J Clin Neonatol 2014;3:240
- Individual participant dataSharing planned: No
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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.
Alisa Niksch, MD study director
Study Sponsor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Injury, run by Owlet Baby Care, Inc. at 2 sites 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 4 inclusion and 5 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 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Incidence of Clinically Important Skin Reactions (time frame: From baseline to study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05561946, which also lists 3 linked publications.
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 30 Sep 2022.