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
49
Subjects are to pump 15 min with the comparator device
Subjects are to pump 15 min with the investigational device
Medela AG
Baar, Canton of Zug, Switzerland
PAMR
Breast drainage, determined by the metric percent of available milk removed (PAMR).
Time frame: 7-21 days
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.
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