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Babies are the best in class in order to get human milk out of a lactating breast. With this in mind, Philips has developed the a new electric breast pump, attempting to mimic the babies sucking behavior. The new electric breast pump includes a new vacuum profile and 2 new expression kits.
Breast pumps currently on the market function by applying vacuum directly to the breast. The effect of a build-up of pressure within the breast due to the accumulation of milk, combined with the external negative pressure introduced by the breast pump, results in the expression of milk. However, in order to express sufficient amounts of milk it is important to stimulate the Milk Ejection Reflex (MER). The MER, also called letdown, draught ejection, expulsion or pumping reflex, is described as a response of the mammary gland to oxytocin. When the nipple is stimulated, the mother's posterior pituitary gland releases oxytocin into the bloodstream. Upon reaching the breast tissue, oxytocin provokes contraction of cells within the structure of the breast causing milk flow. Without the MER successful breastfeeding or breast milk expression cannot happen. In order to stimulate the MER, Philips has developed 2 new expression kits to better mimic the suckling pattern of an infant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1K expression kit | Experimental | Subjects will be using the breastpump with the with 1K expression kit. |
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| 2K expression kit | Experimental | Subjects will be using the breastpump with the with 2K expression kit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Using Eureka Breast Pump with Expression Kit | Device | Each subject will undergo two expression sessions for single and double electric pumping in randomized order to reduce the variation. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the performance via percentage of the end milk weight that is expressed during the first 5 minutes after pump start of the Eureka electric breast pump and 1K and 2K expression kits. | The data of the expression sessions will be averaged within each of the single and double pumping regimes. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the performance weight of expressed milk at 1-minute intervals of the Eureka electric breast pump and 1K and 2K expression kits. | The data of the expression sessions will be averaged within each of the single and double pumping regimes. | 3 months |
| Evaluating the performance via total expression time in minutes of the Eureka electric breast pump and 1K and 2K expression kits. |
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Inclusion Criteria:
Exclusion Criteria:
Breast feeding women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philips Innovation Site Eindhoven | Eindhoven | 5656 AE | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | World Health Organzation: http://www.who.int/topics/breastfeeding/en/. | ||
| 26869575 | Background | Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7. | |
| 9281906 |
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The Investigational Device used for this study, is an electric breast pump, intended to express and collect milk from the breast of a lactating woman. Both the 1K and 2K expression kit will be tested in single and double pumping regime.
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The data of the expression sessions will be averaged within each of the single and double pumping regimes. |
| 3 months |
| Evaluating the performance of time to first milk ejection reflex (MER) pump in seconds of the Eureka electric breast pump and 1K and 2K expression kits. | The data of the expression sessions will be averaged within each of the single and double pumping regimes. | 3 months |
| Evaluating the performance via weight (grams) of expressed milk after full expression session of the Eureka electric breast pump and 1K and 2K expression kits. | The data of the expression sessions will be averaged within each of the single and double pumping regimes. | 3 months |
| Background |
| Zoppou C, Barry SI, Mercer GN. Dynamics of human milk extraction: a comparative study of breast feeding and breast pumping. Bull Math Biol. 1997 Sep;59(5):953-73. doi: 10.1007/BF02460001. |
| 16280556 | Background | Riordan J, Gill-Hopple K, Angeron J. Indicators of effective breastfeeding and estimates of breast milk intake. J Hum Lact. 2005 Nov;21(4):406-12. doi: 10.1177/0890334405281032. |
| ID | Term |
|---|---|
| D061186 | Breast Milk Expression |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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