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| Name | Class |
|---|---|
| Clinical Trial Unit, University Hospital Basel, Switzerland | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PersonalFit - Breast shield | Device | Subjects are to pump 15 min with the comparator device |
|
| Measure | Description | Time Frame |
|---|---|---|
| PAMR | Breast drainage, determined by the metric percent of available milk removed (PAMR). | 7-21 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Due to the nature of the study device (breastshiled to be used for expressing breastmilk) only lactating females can be enrolled into the study.
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| Name | Affiliation | Role |
|---|---|---|
| Lennart Ivarsson, PhD | Employee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medela AG | Baar | Canton of Zug | 6341 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32401335 | Derived | Sakalidis VS, Ivarsson L, Haynes AG, Jager L, Scharer-Hernandez NG, Mitoulas LR, Prime DK. Breast shield design impacts milk removal dynamics during pumping: A randomized controlled non-inferiority trial. Acta Obstet Gynecol Scand. 2020 Nov;99(11):1561-1567. doi: 10.1111/aogs.13897. Epub 2020 Jun 5. |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| Brownie - Breast shield | Device | Subjects are to pump 15 min with the investigational device |
|
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. |