NCT03091985

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Medela AG · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Lactation

Interventions

Type	Name	Description
DEVICE	PersonalFit - Breast shield	Subjects are to pump 15 min with the comparator device
DEVICE	Brownie - Breast shield	Subjects are to pump 15 min with the investigational device

Timeline

• Start date: 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 across 1 country: Switzerland