An Observational Study of Skin Reaction in Infants Using the Owlet Sock OSS 3.0

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Observational Study of Skin Reaction in Infants Using the Owlet Sock OSS 3.0

Conditions
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Skin Injury

Intervention / Treatment
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* Device: Owlet OSS 3.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 44 Weeks
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospitalized Infants<br>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. | Device: Owlet OSS 3.0<br>* 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<br>|
| Healthy Infants<br>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. | Device: Owlet OSS 3.0<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline to study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin reaction resolution | Measure the time intervals for resolution of a skin finding related to wear of the device. | 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. | 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. | From initiation of study intervention to end of study intervention, approximately 14 days. |