Evaluation of Fluid-Filled Expression Core Technology Study - I
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medela AG
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Recording all Adverse Events
研究概览
简要总结
A functional model of a fluid-filled, smaller dead volume breast pump has been developed in order to more closely mimic the breastfeeding infant. The technology of fluid-filled pumping has been tested in one prior clinical study and has now progressed to a complete prototype with which the user can assemble, pump, disassemble, clean and reuse.
详细描述
Current breast pumps function in a way that is different to breastfeeding. These include the seal to the breast, the movement of the nipple, the sensations of warmth and moisture, the variability in frequency, and the strength of the applied vacuum. During breastfeeding the mother's nipple and the infant's mouth form a chamber that is a fluid-filled, no dead volume system, which is needed to create a working vacuum to remove milk from the breast. There is no air visible in the natural system according to ultrasound measurements. This is unlike breast pumps which use an air-filled, large dead volume system, to create a working vacuum. Therefore, a functional model of a fluid-filled, smaller dead volume breast pump has been developed in order to more closely mimic the breastfeeding infant. The technology of fluid-filled pumping has been tested in one prior clinical study and has now progressed to a complete prototype with which the user can assemble, pump, disassemble, clean and reuse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject ≥ 18 years old
- •Infant is ≥1 and ≤6 month old
- •Subject and baby are healthy according to self-declaration in the "Mother and infant health questionnaire"
- •Subject is predominantly breastfeeding (80% of all feeds, i.e. ≤150 ml formula/day or equal representative amount of solid food)
- •The subject agrees to pump or feed the last time a minimum of 2 hours (hr) before the start of the pumping session at the study site
- •The subject agrees to photographs/3 D scan of the breast and upper body (no face),
- •The subject agrees to a video while pumping
- •The subject signs the informed consent documentation
- •Subject agrees that a maximum of 2 male team members can be present in the room to conduct the usability part of the study
- •The mother accepts that the pumped milk in visit 2 must be donated to the study i.e. cannot be fed to the baby
排除标准
- •The subject has a nipple size ≥ 21 mm
- •Mastitis (any breast within two weeks prior to enrolment)
- •Engorgement (any breast within two weeks prior to enrolment).
- •Case of current infection as self-declared in the Mother and infant health questionnaire
结局指标
主要结局
Recording all Adverse Events
时间窗: 3 months
Recording all AE and evaluating the (time of) occurrence, type, seriousness, expectedness, relatedness, and outcome of the adverse events
Observing pump performance
时间窗: 3 months
Measuring milk flow volume including time to first ejection.
次要结局
- Measureing user acceptance(3 months)