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Influence of the Brownie Breast Shield on the Dynamics of Milk Removal (BDM)

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ClinicalTrials.gov Identifier: NCT03091985
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
Medela AG

Brief 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.


Condition or disease Intervention/treatment Phase
Lactation Device: PersonalFit - Breast shield Device: Brownie - Breast shield Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Influence of the Brownie Breast Shield on the Dynamics of Milk Removal
Actual Study Start Date : March 31, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : December 19, 2017

Arm Intervention/treatment
Experimental: Group A

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

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

Experimental: Group B

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

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




Primary Outcome Measures :
  1. PAMR [ Time Frame: 7-21 days ]
    Breast drainage, determined by the metric percent of available milk removed (PAMR).


Secondary Outcome Measures :
  1. Milk volume [ Time Frame: 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

  2. Mid fat content [ Time Frame: 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

  3. Hind fat content [ Time Frame: 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

  4. Device usability [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Due to the nature of the study device (breastshiled to be used for expressing breastmilk) only lactating females can be enrolled into the study.
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091985


Locations
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Switzerland
Medela AG
Baar, Zug, Switzerland, 6341
Sponsors and Collaborators
Medela AG
Clinical Trial Unit, University Hospital Basel, Switzerland
Investigators
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Principal Investigator: Lennart Ivarsson, PhD Employee

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Responsible Party: Medela AG
ClinicalTrials.gov Identifier: NCT03091985     History of Changes
Other Study ID Numbers: MHM1601
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medela AG:
Breastshield
Breastpump
Breastfeeding