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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 : Completed
First Posted : May 22, 2019
Last Update Posted : November 11, 2019
Sponsor:
Information provided by (Responsible Party):
Philips Consumer Lifestyle

Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date November 11, 2019
Actual Study Start Date  ICMJE May 17, 2019
Actual Primary Completion Date October 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
Evaluating the performance of the Eureka single and double electric breast pump, and 1K and 2K expression kits [ Time Frame: 3 months ]
Percentage of the end milk weight that is expressed during the first 5 minutes after pump start.
Change History Complete list of historical versions of study NCT03960190 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Evaluating the performance of the Eureka single and double electric breast pump, and 1K and 2K expression kits [ Time Frame: 3 months ]
    Weight of expressed milk at 1-minute intervals
  • Evaluating the performance of the Eureka single and double electric breast pump, and 1K and 2K expression kits [ Time Frame: 3 months ]
    Total expression time
  • Evaluating the performance of the Eureka single and double electric breast pump, and 1K and 2K expression kits [ Time Frame: 3 months ]
    Time to first milk ejection reflex (MER)
  • Evaluating the performance of the Eureka single and double electric breast pump, and 1K and 2K expression kits [ Time Frame: 3 months ]
    Weight of expressed milk after full expression session
  • Evaluating the performance of the Eureka single and double electric breast pump, and 1K and 2K expression kits [ Time Frame: 3 months ]
    Scores awarded for the questionnaires.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Investigation to Assess the Performance of the Eureka Electric Breast Pump in Mothers Breastfeeding Their Healthy Term Infant
Official Title  ICMJE Clinical Investigation to Assess the Performance of the Eureka Electric Breast Pump in Mothers Breastfeeding Their Healthy Term Infant
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Breast Pumping
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: 1K expression kit
    Subjects will be using the breastpump with the with 1K expression kit.
    Intervention: Device: Using Eureka Breast Pump with Expression Kit
  • Experimental: 2K expression kit
    Subjects will be using the breastpump with the with 2K expression kit.
    Intervention: Device: Using Eureka Breast Pump with Expression Kit
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2019)
40
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
44
Actual Study Completion Date  ICMJE October 22, 2019
Actual Primary Completion Date October 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Breast feeding women
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960190
Other Study ID Numbers  ICMJE HW-MCC-Eureka-2019-10559
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Philips Consumer Lifestyle
Study Sponsor  ICMJE Philips Consumer Lifestyle
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Philips Consumer Lifestyle
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP