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OpenTrials
Completed

NCT Number: NCT03091985

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

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.

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Key information

Conditions

Lactation Behavior Breast Feeding Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medela AG

Baar, Canton of Zug, 6341, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject ≥ 18 years old
  • Infant is ≥1 and ≤6 month old
  • Subject is predominantly breastfeeding (80% of all feeds, i.e. ≤150 ml formula/day or equal representative amount of solid food)
  • 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
  • The subject agrees to photographs of the breast and upper body (no face)
  • The subject agrees to perform a 24 hour milk production at home, inclusive weighing the Infant before and after each feeding
  • The subject agrees to collect ~2 ml of milk before and after each feeding for fat analysis
  • The subject signed the Informed Consent Form

Exclusion criteria

  • Mastitis (any breast within two weeks prior enrolment)
  • Engorgement (any breast within two weeks prior enrolment)

Treatment and study plan

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

Primary outcomes

  1. PAMR

    Time frame: 7-21 days

    Breast drainage, determined by the metric percent of available milk removed (PAMR).

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medela AG

Industry

Collaborators

  • Clinical Trial Unit, University Hospital Basel, Switzerland

Registry information

Acronym: BDM

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 27, 2017
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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