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

Breast Pumping Clinical Trial

— EUREKA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03960190
• Other study ID #: HW-MCC-Eureka-2019-10559
• Status: Completed
• Phase: N/A
• Start date: May 17, 2019
• Est. completion date: October 22, 2019

Study information

• Verified date: November 2019
• Source: Philips Consumer Lifestyle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 22, 2019
• Est. primary completion date: October 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Pumping

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Philips Innovation Site Eindhoven	Eindhoven

Sponsors (1)

Lead Sponsor	Collaborator
Philips Consumer Lifestyle

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View Citation

Victora CG, Bahl R, Barros AJ, França 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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