Influence of the Brownie Breast Shield on the Dynamics of Milk Removal

Not Applicable

Completed

• Conditions: Lactation
• Interventions: Device: PersonalFit - Breast shield; Device: Brownie - Breast shield

• Registration Number: NCT03091985
• Lead Sponsor: Medela AG

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.

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 Timeline

• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-27
• Study Start: 2017-03-31
• Primary Completion: 2017-09-30
• Study Completion: 2017-12-19
• Status Verified: 2018-02
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Brownie - Breast shield	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
Group B	Brownie - Breast shield	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
Group B	PersonalFit - Breast shield	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
Group A	PersonalFit - Breast shield	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

Primary Outcome Measures

Name	Time	Method
PAMR	7-21 days	Breast drainage, determined by the metric percent of available milk removed (PAMR).

Secondary Outcome Measures

Name	Time	Method
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.	Expressed breast milk volume
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.	Breast milk - mid fat content
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.	Breast milk - hind fat content
Device usability	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

Trial Locations

Locations (1)

Medela AG; 🇨🇭 Baar, Zug, Switzerland