Clinical Investigation to Assess the Performance of the Eureka Electric Breast Pump in Mothers Breastfeeding Their Healthy Term Infant

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Investigation to Assess the Performance of the Eureka Electric Breast Pump in Mothers Breastfeeding Their Healthy Term Infant

Conditions
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Breast Pumping

Intervention / Treatment
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* Device: Using Eureka Breast Pump with Expression Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have an age between 18 and 50 years Have delivered a healthy, term singleton infant (with birth weight above 2.5kg and at least 37 weeks gestation) Have a baby with an age between 1 and 4 months Exclusively breastfeeding at the time of the study Have signed the Informed Consent form Exclusion Criteria: Pregnant at the time of the study Suffer from known side effects (sore nipples, nipple trauma, bruising, engorgement, clogged mammary ducts, lactostasis, mastitis) at the time of the study Suffer from syndrome of Raynaud When providing complementary foods to their baby at the time of the study When providing donor milk and/or formula milk to their baby at the time of the study When having their period at the time of the study When taking oral anticonception at the time of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1K expression kit<br>Subjects will be using the breastpump with the with 1K expression kit. | Device: Using Eureka Breast Pump with Expression Kit<br>* Each subject will undergo two expression sessions for single and double electric pumping in randomized order to reduce the variation.<br>|
| Experimental: 2K expression kit<br>Subjects will be using the breastpump with the with 2K expression kit. | Device: Using Eureka Breast Pump with Expression Kit<br>* Each subject will undergo two expression sessions for single and double electric pumping in randomized order to reduce the variation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |