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

Not Applicable

Completed

• Conditions: Breast Pumping
• Interventions: Device: Using Eureka Breast Pump with Expression Kit

• Registration Number: NCT03960190
• Lead Sponsor: Philips Consumer Lifestyle

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-05-15
• Study Start: 2019-05-17
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-22
• Primary Completion: 2019-10-22
• Study Completion: 2019-10-22
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-08
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2K expression kit	Using Eureka Breast Pump with Expression Kit	Subjects will be using the breastpump with the with 2K expression kit.
1K expression kit	Using Eureka Breast Pump with Expression Kit	Subjects will be using the breastpump with the with 1K expression kit.

Primary Outcome Measures

Name	Time	Method
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.	3 months	The data of the expression sessions will be averaged within each of the single and double pumping regimes.

Secondary Outcome Measures

Name	Time	Method
Evaluating the performance via total expression time in minutes of the Eureka electric breast pump and 1K and 2K expression kits.	3 months	The data of the expression sessions will be averaged within each of the single and double pumping regimes.
Evaluating the performance weight of expressed milk at 1-minute intervals of the Eureka electric breast pump and 1K and 2K expression kits.	3 months	The data of the expression sessions will be averaged within each of the single and double pumping regimes.
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.	3 months	The data of the expression sessions will be averaged within each of the single and double pumping regimes.
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.	3 months	The data of the expression sessions will be averaged within each of the single and double pumping regimes.

Trial Locations

Locations (1)

Philips Innovation Site Eindhoven; 🇳🇱 Eindhoven, Netherlands