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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lactation

Intervention / Treatment
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* Device: PersonalFit - Breast shield
* Device: Brownie - Breast shield


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject ≥ 18 years old Infant is ≥1 and ≤6 month old Subject is predominantly breastfeeding (80% of all feeds, i.e. ≤150 ml formula/day or equal representative amount of solid food) 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 The subject agrees to photographs of the breast and upper body (no face) The subject agrees to perform a 24 hour milk production at home, inclusive weighing the Infant before and after each feeding The subject agrees to collect  2 ml of milk before and after each feeding for fat analysis The subject signed the Informed Consent Form Exclusion Criteria: Mastitis (any breast within two weeks prior enrolment) Engorgement (any breast within two weeks prior enrolment)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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<br>* Subjects are to pump 15 min with the comparator device<br>Device: Brownie - Breast shield<br>* Subjects are to pump 15 min with the investigational device<br>|
| Experimental: Group B<br>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<br>* Subjects are to pump 15 min with the comparator device<br>Device: Brownie - Breast shield<br>* Subjects are to pump 15 min with the investigational device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAMR | Breast drainage, determined by the metric percent of available milk removed (PAMR). | 7-21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Milk volume | Expressed breast 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. | 
| Mid fat content | Breast milk - 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. | 
| Hind fat content | Breast milk - 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. | 
| Device usability | Device usability questionnaire | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastshield, Breastpump, Breastfeeding