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

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.

Study Overview

• Status: Completed
• Conditions: Breast Pumping
• Intervention / Treatment: Device: Using Eureka Breast Pump with Expression Kit

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Eindhoven, Netherlands, 5656 AE
    • Philips Innovation Site Eindhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Philips Consumer Lifestyle

Publications and helpful links

General Publications

• 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.
• World Health Organzation: http://www.who.int/topics/breastfeeding/en/.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2019
• Primary Completion (Actual): October 22, 2019
• Study Completion (Actual): October 22, 2019

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 8, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HW-MCC-Eureka-2019-10559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No