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

Philips

Status

Completed

Conditions

Breast Pumping

Treatments

Device: Using Eureka Breast Pump with Expression Kit

Study type

Interventional

Funder types

Industry

Identifiers

NCT03960190

HW-MCC-Eureka-2019-10559

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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