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

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ClinicalTrials.gov Identifier: NCT03960190
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Pumping Device: Using Eureka Breast Pump with Expression Kit Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation to Assess the Performance of the Eureka Electric Breast Pump in Mothers Breastfeeding Their Healthy Term Infant
Actual Study Start Date : May 17, 2019
Estimated Primary Completion Date : June 28, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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.




Primary Outcome Measures :
  1. 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. [ Time Frame: 3 months ]
    The data of the expression sessions will be averaged within each of the single and double pumping regimes.


Secondary Outcome Measures :
  1. Evaluating the performance weight of expressed milk at 1-minute intervals of the Eureka electric breast pump and 1K and 2K expression kits. [ Time Frame: 3 months ]
    The data of the expression sessions will be averaged within each of the single and double pumping regimes.

  2. Evaluating the performance via total expression time in minutes of the Eureka electric breast pump and 1K and 2K expression kits. [ Time Frame: 3 months ]
    The data of the expression sessions will be averaged within each of the single and double pumping regimes.

  3. 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. [ Time Frame: 3 months ]
    The data of the expression sessions will be averaged within each of the single and double pumping regimes.

  4. 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. [ Time Frame: 3 months ]
    The data of the expression sessions will be averaged within each of the single and double pumping regimes.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast feeding women
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960190


Contacts
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Contact: Anouk Schroeten-van der Lans, Phd 00316 28355649 anouk.van.der.lans@philips.com
Contact: Jeroen Knaapen, MSc 0031 6 386 91 066 jeroen.knaapen@philips.com

Locations
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Netherlands
Philips Innovation Site Eindhoven Recruiting
Eindhoven, Netherlands, 5656 AE
Contact: Anouk Schroeten-van der Lans, PhD    00316 28355649    anouk.van.der.lans@philips.com   
Contact: Jeroen Knaapen, MSc    0031 6 386 91 066    jeroen.knaapen@philips.com   
Sponsors and Collaborators
Philips Consumer Lifestyle

Publications:
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Responsible Party: Philips Consumer Lifestyle
ClinicalTrials.gov Identifier: NCT03960190     History of Changes
Other Study ID Numbers: HW-MCC-Eureka-2019-10559
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No