Breast PumpingEUREKANCT03960190

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

A study testing Using Eureka Breast Pump with Expression Kit in people with Breast Pumping, run by Philips Consumer Lifestyle at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Pumping
What is being tested?: Using Eureka Breast Pump with Expression Kit
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteNetherlands
Study dates: 17 May 2019to 22 Oct 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Philips Innovation Site Eindhoven
Eindhoven, 5656 AE

Other trials in Netherlands

About this study

Read the 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.

Conditions: Breast Pumping
Being tested: Using Eureka Breast Pump with Expression Kit
Medical subject headings: Breast Milk Expression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Using Eureka Breast Pump with Expression KitDevice
Each subject will undergo two expression sessions for single and double electric pumping in randomized order to reduce the variation.

Study groups in NCT03960190
Study group	Role	What they receive
1K expression kit	Experimental	Subjects will be using the breastpump with the with 1K expression kit. Receives: Device: Using Eureka Breast Pump with Expression Kit
2K expression kit	Experimental	Subjects will be using the breastpump with the with 2K expression kit. Receives: Device: Using Eureka Breast Pump with Expression Kit

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months

Secondary outcomes (4)

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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 May 201922 Oct 2019

First posted22 May 2019
Study start17 May 2019
Primary completion22 Oct 2019
Study completion22 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Breast PumpingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
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)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03960190
Sponsor's protocol ID: HW-MCC-Eureka-2019-10559
Acronym: EUREKA
Status last verified: Nov 2019
First submitted: 15 May 2019
Last updated: 12 Nov 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

World Health Organzation: http://www.who.int/topics/breastfeeding/en/.
Victora CG, Bahl R, Barros AJ, Franca 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.
PubMed 26869575
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. doi: 10.1007/BF02460001.
PubMed 9281906
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. doi: 10.1177/0890334405281032.
PubMed 16280556

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Pumping trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation to Assess the Performance of the Eureka Electric Breast Pump in Mothers Breastfeeding Their Healthy Term Infant
ClinicalTrials.gov ID: NCT03960190
Acronym / sponsor ID: EUREKA / HW-MCC-Eureka-2019-10559
Conditions: Breast Pumping
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Philips Consumer LifestyleIndustry (pharma, biotech, devices)
Study start: 17 May 2019 (actual)
Primary completion: 22 Oct 2019 (actual)
Study completion: 22 Oct 2019 (actual)
First posted: 22 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
1K expression kit	Experimental	Device: Using Eureka Breast Pump with Expression KitSubjects will be using the breastpump with the with 1K expression kit.
2K expression kit	Experimental	Device: Using Eureka Breast Pump with Expression KitSubjects will be using the breastpump with the with 2K expression kit.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Using Eureka Breast Pump with Expression KitEach subject will undergo two expression sessions for single and double electric pumping in randomized order to reduce the variation.	Device	1K expression kit, 2K expression kit

Primary outcome

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.

4 secondary outcomes

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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
BackgroundWorld Health Organzation: http://www.who.int/topics/breastfeeding/en/.
Background: PubMed 26869575Victora CG, Bahl R, Barros AJ, Franca 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.
Background: PubMed 9281906Zoppou 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. doi: 10.1007/BF02460001.
Background: PubMed 16280556Riordan 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. doi: 10.1177/0890334405281032.
Individual participant dataSharing planned: No

Related trials for Breast Pumping

Recruiting
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Breastfeeding, Prematurity
Not yet recruitingPhase 1
A Study to Investigate the Effect of Omeprazole and Cyclosporine on Velzatinib in Healthy Participants
Healthy Participants, Gastrointestinal Neoplasms
RecruitingPhase 4
Postpartum Vaginal Estrogen for Breastfeeding Patients
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Not yet recruiting
The Effect of Web-Based Counselling on Breastfeeding Experiences and Infant Care Competence Among Mothers of Preterm Babies
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Recruiting
Pumping to Up Maternal Milk Production for Preterms
Breastfeeding, Breastmilk Expression

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Using Eureka Breast Pump with Expression Kit in people with Breast Pumping, run by Philips Consumer Lifestyle at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03960190, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.