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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-17

Study Completion Date

2019-10-22

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.

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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.

Conditions

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Breast Pumping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1K expression kit

Subjects will be using the breastpump with the with 1K expression kit.

Group Type EXPERIMENTAL

Using Eureka Breast Pump with Expression Kit

Intervention Type DEVICE

Each subject will undergo two expression sessions for single and double electric pumping in randomized order to reduce the variation.

2K expression kit

Subjects will be using the breastpump with the with 2K expression kit.

Group Type EXPERIMENTAL

Using Eureka Breast Pump with Expression Kit

Intervention Type DEVICE

Each subject will undergo two expression sessions for single and double electric pumping in randomized order to reduce the variation.

Interventions

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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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes