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

Medela

Status: Completed

Conditions: Lactation

Treatments: Device: PersonalFit - Breast shield; Device: Brownie - Breast shield

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03091985

MHM1601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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49 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Device: Brownie - Breast shield

Device: PersonalFit - Breast shield

Group B

Experimental group

Description:

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

Treatment:

Device: Brownie - Breast shield

Device: PersonalFit - Breast shield