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

N/ACompletedNCT03091985

Medela AG49 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Lactation

Interventions

PersonalFit - Breast shieldDEVICE

Subjects are to pump 15 min with the comparator device

Brownie - Breast shieldDEVICE

Subjects are to pump 15 min with the investigational device

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Medela AG

Baar, Canton of Zug, Switzerland

Outcomes

Primary Outcomes

PAMR

Breast drainage, determined by the metric percent of available milk removed (PAMR).

Time frame: 7-21 days

Secondary Outcomes

Milk volume

Expressed breast 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.

Mid fat content

Breast milk - 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.

Hind fat content

Breast milk - 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.

Device usability

Device usability questionnaire

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.

Data from ClinicalTrials.gov

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