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

Lactation Clinical Trial

— BDM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091985
• Other study ID #: MHM1601
• Status: Completed
• Phase: N/A
• Start date: March 31, 2017
• Est. completion date: December 19, 2017

Study information

• Verified date: February 2018
• Source: Medela AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 19, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lactation

Intervention

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

Locations

Country	Name	City	State
Switzerland	Medela AG	Baar	Zug

Sponsors (2)

Lead Sponsor	Collaborator
Medela AG	Clinical Trial Unit, University Hospital Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PAMR	Breast drainage, determined by the metric percent of available milk removed (PAMR).	7-21 days
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.