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

NCT03091985 — Not applicable, Completed, 49 participants, Medela AG

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT03091985, acronym BDM
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: single, supportive care
Enrollment	49 (Actual)
Sponsor	Medela AG (Industry); collaborators: Clinical Trial Unit, University Hospital Basel, Switzerland
Conditions	Lactation
Interventions	PersonalFit - Breast shield, Brownie - Breast shield (Device)
Dates	start 2017-03-31, primary completion 2017-09-30, completion 2017-12-19, first posted 2017-03-27, last updated 2020-02-10
Locations	1 site in Switzerland

-Summary

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.

Expand all sections · Collapse all

+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
Group A	Experimental	Device: PersonalFit - Breast shield; Device: Brownie - Breast shield	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	Device: PersonalFit - Breast shield; Device: Brownie - Breast shield	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

PersonalFit - Breast shield (Device): Subjects are to pump 15 min with the comparator device
Brownie - Breast shield (Device): Subjects are to pump 15 min with the investigational device

+Outcome measures

Primary outcomes

PAMR [7-21 days]: Breast drainage, determined by the metric percent of available milk removed (PAMR).

Secondary outcomes

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.]: Expressed breast milk volume
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.]: Breast milk - mid fat content
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.]: Breast milk - hind fat content
Device usability [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 questionnaire

+Eligibility

Sex: Female, ages: 18 Years to any, 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)

+Locations (1)

Facility	City	Country	Status
Medela AG	Baar, Canton of Zug	Switzerland

+Publications

Results publication: 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. PMID 32401335

+Investigators

Lennart Ivarsson, PhD, Principal investigator, Employee