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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation of Fluid Expression Technology | Other | This study aims to provide important insights with respect to the safety, performance, and real-life usability of pumping technology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast Pump | Device | Hydraulic Breast pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recording all Adverse Events | Recording all AE and evaluating the (time of) occurrence, type, seriousness, expectedness, relatedness, and outcome of the adverse events | 3 months |
| Observing pump performance | Measuring milk flow volume including time to first ejection. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measureing user acceptance | Analysing the User Experience Questionnaire as per Laugwitz, Held & Schrepp (2017) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beatrix Mascher, MBA | Clinical Affairs within Medical Reseach and R&D | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medela AG | Baar | 6431 | Switzerland |
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| ID | Term |
|---|---|
| D061186 | Breast Milk Expression |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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Pilot study
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