LactationBDMNCT03091985

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

A study testing PersonalFit - Breast shield and Brownie - Breast shield in people with Lactation, run by Medela AG at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Lactation
What is being tested?: PersonalFit - Breast shield and Brownie - Breast shield
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 1 siteSwitzerland
Study dates: 31 Mar 2017to 19 Dec 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Medela AG
Baar, Canton of Zug, 6341

Other trials in Switzerland

About this study

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.

Read the 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
Being tested: PersonalFit - Breast shield, Brownie - Breast shield
Keywords: Breastshield, Breastpump, Breastfeeding
Medical subject headings: Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PersonalFit - Breast shieldDevice
Subjects are to pump 15 min with the comparator device
Brownie - Breast shieldDevice
Subjects are to pump 15 min with the investigational device

Study groups in NCT03091985
Study group	Role	What they receive
Group A	Experimental	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 Receives: Device: PersonalFit - Breast shield; Device: Brownie - Breast shield
Group B	Experimental	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 Receives: Device: PersonalFit - Breast shield; Device: Brownie - Breast shield

What is being measured

The primary outcome is the main question the study is designed to answer.

PAMR
Breast drainage, determined by the metric percent of available milk removed (PAMR).
Measured: 7-21 days

Secondary outcomes (4)

Milk volume
Expressed breast milk volume
Measured: 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.
Mid fat content
Breast milk - mid fat content
Measured: 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.
Hind fat content
Breast milk - hind fat content
Measured: 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
Device usability questionnaire
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 201719 Dec 2017

First posted27 Mar 2017
Study start31 Mar 2017
Primary completion30 Sep 2017
Study completion19 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for LactationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03091985
Sponsor's protocol ID: MHM1601
Acronym: BDM
Status last verified: Feb 2018
First submitted: 15 Mar 2017
Last updated: 10 Feb 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sakalidis VS, Ivarsson L, Haynes AG, Jager L, Scharer-Hernandez NG, Mitoulas LR, Prime DK. Breast shield design impacts milk removal dynamics during pumping: A randomized controlled non-inferiority trial. Acta Obstet Gynecol Scand. 2020 Nov;99(11):1561-1567. doi: 10.1111/aogs.13897. Epub 2020 Jun 5.
PubMed 32401335

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding

All Lactation trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of the Brownie Breast Shield on the Dynamics of Milk Removal
ClinicalTrials.gov ID: NCT03091985
Acronym / sponsor ID: BDM / MHM1601
Conditions: Lactation
Keywords: Breastshield, Breastpump, Breastfeeding
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Medela AGIndustry (pharma, biotech, devices)
Collaborators: Clinical Trial Unit, University Hospital Basel, Switzerland
Study start: 31 Mar 2017 (actual)
Primary completion: 30 Sep 2017 (actual)
Study completion: 19 Dec 2017 (actual)
First posted: 27 Mar 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Device: PersonalFit - Breast shield, Device: Brownie - Breast shieldDrainage 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
Group B	Experimental	Device: PersonalFit - Breast shield, Device: Brownie - Breast shieldDrainage 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

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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)

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PersonalFit - Breast shieldSubjects are to pump 15 min with the comparator device	Device	Group A, Group B
Brownie - Breast shieldSubjects are to pump 15 min with the investigational device	Device	Group A, Group B

Primary outcome

PAMR
Time frame: 7-21 days
Breast drainage, determined by the metric percent of available milk removed (PAMR).

4 secondary outcomes

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.
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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
Derived from this study: PubMed 32401335Sakalidis VS, Ivarsson L, Haynes AG, Jager L, Scharer-Hernandez NG, Mitoulas LR, Prime DK. Breast shield design impacts milk removal dynamics during pumping: A randomized controlled non-inferiority trial. Acta Obstet Gynecol Scand. 2020 Nov;99(11):1561-1567. doi: 10.1111/aogs.13897. Epub 2020 Jun 5.
Individual participant dataSharing planned: No

Related trials for Lactation

RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lennart Ivarsson, PhD principal investigator

Employee

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PersonalFit - Breast shield and Brownie - Breast shield in people with Lactation, run by Medela AG at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PAMR (time frame: 7-21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03091985, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.