Influence of the Brownie Breast Shield on the Dynamics of Milk Removal (BDM)

The purpose of this study is to investigate the efficacy of breast drainage of the healthy breast with the new Medela pump set breast shield (Brownie).

The objective of the study is to verify the Brownie breast shield to be non-inferior to the current PersonalFit breast shield in emptying the healthy lactating breast.

Study Overview

• Status: Completed
• Conditions: Lactation
• Intervention / Treatment: Device: PersonalFit - Breast shield; Device: Brownie - Breast shield

Detailed Description

In this study we could show that the Brownie shield is non-inferior to the PersonalFit shield in all four endpoints, superior to the PersonalFit shield in terms of PAMR and expressed milk volume, and is more comfortable than the PersonalFit shield according to participant surveys.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zug
    • Baar, Zug, Switzerland, 6341
      • Medela AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Subject ≥ 18 years old
2. Infant is ≥1 and ≤6 month old
3. Subject is predominantly breastfeeding (80% of all feeds, i.e. ≤150 ml formula/day or equal representative amount of solid food)
4. The subject agrees to pump or feed the last time a minimum of 3 hours before the start of the pumping session at the study site
5. The subject agrees to photographs of the breast and upper body (no face)
6. The subject agrees to perform a 24 hour milk production at home, inclusive weighing the Infant before and after each feeding
7. The subject agrees to collect ~2 ml of milk before and after each feeding for fat analysis
8. The subject signed the Informed Consent Form

Exclusion Criteria:

1. Mastitis (any breast within two weeks prior enrolment)
2. Engorgement (any breast within two weeks prior enrolment)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Drainage of the lactating breast using: PersonalFit - Breast shield & Brownie - Breast shield Breast shields are each to be used for 15 min pumping with the symphony breastpump	Device: PersonalFit - Breast shield; Subjects are to pump 15 min with the comparator device; Device: Brownie - Breast shield; Subjects are to pump 15 min with the investigational device
Experimental: Group B; Drainage of the lactating breast using: Brownie - Breast shield & PersonalFit - Breast shield Breast shields are each to be used for 15 min pumping with the symphony breastpump	Device: PersonalFit - Breast shield; Subjects are to pump 15 min with the comparator device; Device: Brownie - Breast shield; Subjects are to pump 15 min with the investigational device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAMR	Breast drainage, determined by the metric percent of available milk removed (PAMR).	7-21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Milk volume	Expressed breast milk volume	After 15 minutes of controlled pumping with the test or comparator device. Each participant will pump twice with a "washout period" of 7-21 days in between the corresponding occasions.
Mid fat content	Breast milk - mid fat content	After 15 minutes of controlled pumping with the test or comparator device. Each participant will pump twice with a "washout period" of 7-21 days in between the corresponding occasions.
Hind fat content	Breast milk - hind fat content	After 15 minutes of controlled pumping with the test or comparator device. Each participant will pump twice with a "washout period" of 7-21 days in between the corresponding occasions.
Device usability	Device usability questionnaire	After 15 minutes of controlled pumping with the test or comparator device. Each participant will pump twice with a "washout period" of 7-21 days in between the corresponding occasions.

Collaborators and Investigators

• Sponsor: Medela AG
• Collaborators: Clinical Trial Unit, University Hospital Basel, Switzerland
• Investigators: Principal Investigator: Lennart Ivarsson, PhD, Employee

Publications and helpful links

General Publications

• Sakalidis VS, Ivarsson L, Haynes AG, Jager L, Scharer-Hernandez NG, Mitoulas LR, Prime DK. Breast shield design impacts milk removal dynamics during pumping: A randomized controlled non-inferiority trial. Acta Obstet Gynecol Scand. 2020 Nov;99(11):1561-1567. doi: 10.1111/aogs.13897. Epub 2020 Jun 5.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2017
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): December 19, 2017

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Breastfeeding; Breastshield; Breastpump
• Other Study ID Numbers: MHM1601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No