An Observational Study of Skin Reaction in Infants Using the Owlet Sock OSS 3.0
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Incidence of Clinically Important Skin Reactions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 44 Weeks 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of Clinically Important Skin Reactions
时间窗: 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.
次要结局
- Skin reaction resolution(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.(During period of study monitoring, approximately 14 days.)
- Estimate the incidence of any skin reactions, overall and by severity level.(From initiation of study intervention to end of study intervention, approximately 14 days.)