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

NCT03960190 | Completed

• 1 other identifier: HW-MCC-Eureka-2019-10559
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Pumping

Outcome Measures

Primary Outcomes (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.

  The data of the expression sessions will be averaged within each of the single and double pumping regimes.

  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.

  3 months

• Evaluating the performance via total expression time in minutes of the Eureka electric breast pump and 1K and 2K expression kits.

  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.

  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.

  3 months

Study Arms (2)

1K expression kit

EXPERIMENTAL

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

Device: Using Eureka Breast Pump with Expression Kit

2K expression kit

EXPERIMENTAL

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

Device: Using Eureka Breast Pump with Expression Kit

Interventions

Using Eureka Breast Pump with Expression Kit DEVICE

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

1K expression kit; 2K expression kit

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Breast feeding women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Consumer Lifestyle: lead

Study Sites (1)

Philips Innovation Site Eindhoven

Eindhoven, 5656 AE, Netherlands

Location

Related Publications (4)

• World Health Organzation: http://www.who.int/topics/breastfeeding/en/.

  BACKGROUND

• 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.

  PMID: 26869575 BACKGROUND

• 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.

  PMID: 9281906 BACKGROUND

• 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.

  PMID: 16280556 BACKGROUND

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 22, 2019
• Study Start: May 17, 2019
• Primary Completion: October 22, 2019
• Study Completion: October 22, 2019
• Last Updated: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)