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

• ClinicalTrials.gov Identifier: NCT03091985
• Recruitment Status: Completed
• First Posted: March 27, 2017
• Last Update Posted: February 10, 2020
• Sponsor: Medela AG
• Collaborator: Clinical Trial Unit, University Hospital Basel, Switzerland
• Information provided by (Responsible Party): Medela AG

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Lactation	Device: PersonalFit - Breast shield; Device: Brownie - Breast shield	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Influence of the Brownie Breast Shield on the Dynamics of Milk Removal
• Actual Study Start Date: March 31, 2017
• Actual Primary Completion Date: September 30, 2017
• Actual Study Completion Date: December 19, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. PAMR [ Time Frame: 7-21 days ]
   Breast drainage, determined by the metric percent of available milk removed (PAMR).

Secondary Outcome Measures :

1. Milk volume [ Time Frame: 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. ]
   Expressed breast milk volume
2. Mid fat content [ Time Frame: 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. ]
   Breast milk - mid fat content
3. Hind fat content [ Time Frame: 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. ]
   Breast milk - hind fat content
4. Device usability [ Time Frame: 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 questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Due to the nature of the study device (breastshiled to be used for expressing breastmilk) only lactating females can be enrolled into the study.
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

Locations

Switzerland

Medela AG

Baar, Zug, Switzerland, 6341

Sponsors and Collaborators

Medela AG

Clinical Trial Unit, University Hospital Basel, Switzerland

Investigators

• Principal Investigator: Lennart Ivarsson, PhD; Employee

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Medela AG
• ClinicalTrials.gov Identifier: NCT03091985
• Other Study ID Numbers: MHM1601
• First Posted: March 27, 2017
• Last Update Posted: February 10, 2020
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Medela AG:

Breastshield; Breastpump; Breastfeeding