Breast Pumping, Healthy
Conditions
Brief summary
This research involves feasibility testing of design concepts to support device development of an electric breast pump. The purpose is to evaluate a prototype device for feasibility purposes and not health outcomes.
Detailed description
This engineering evaluation involves the voluntary participation of healthy adult lactating women for feasibility testing of breast shield designs. Participants will be asked to rate the breast shield design for fit, comfort, and the ease of use. In addition, participants will be asked to rate a comparison of the device relative to their experiences with their current commercial breast pump and breastfeeding their baby.
Interventions
DEVICEPrototypes of breast shield and Freedom Double Electric Breast Pump
Prototypes of breast shield and Freedom Double Electric Breast Pump.
Sponsors
Momtech Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Prototype breast shield designs for the Freedom Double Electric Breast Pump with \<10 subjects per breast shield design. The study sample size is appropriate for a small feasibility study evaluating design concepts because there are several breast shield designs being evaluated with a small number of subjects per design.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* History of good health * Currently lactating and planning to continue breastfeeding for the next 3 to 4 months * Currently using a commercial electric breast pump at least several times a week * Sufficient milk supply for one missed infant feeding per device testing visit * Willing to attend five device testing visits over 3 to 4 months * Willing to be video recorded during device testing * Willing to discard milk collected during testing
Exclusion criteria
* No active breast or nipple injury, breast inflammation or infection, or nipple piercing * No prior history of breast implant, reduction or reconstruction surgery * Not currently pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast shield comfort | 1 day (Single timepoint) | Rate comfort of device by Questionnaire |
| Breast shield fit | 1 day (Single timepoint) | Rate fit of device by Questionnaire |
| Breast shield ease of use | 1 day (Single timepoint) | Rate ease of use of device by Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of milk expressed | 1 day (Single Timepoint) | Rate volume of milk expressed with device by Questionnaire |
| Participant comparison of device to current commercial breast pump | 1 day (single timepoint) | Rate comparison of device to current breast pump experience by Questionnaire |
| Participant comparison of device to breastfeeding | 1 day (single visit) | Rate comparison of device to breastfeeding experience by Questionnaire |
Countries
United States
Outcome results
None listed