An Observational Study of Skin Reaction in Infants Using the Owlet Sock OSS 3.0
Condition: Skin Injury
Study type: Observational

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.
    

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.
    

Intervention name(s): Owlet OSS 3.0
Intervention type(s): Device
Intervention description(s): 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
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
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.