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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03091985
Other study ID # MHM1601
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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.
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