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LactationBSDNCT02719548

Impact of Breast Shield Designs on Dynamics of Breast Pumping

A study testing Soft edge oval - Hard oval - Modified PF breast shield, Modified PF breast shield - Soft edge oval - Hard oval and Hard oval - Soft edge oval - Modified PF 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

A prospective, randomized, 2-phase/crossover, single center premarket feasibility study. In phase I the comfort will be assessed, the occurence and types of adverse events will be recorded and the assessment how and if the different breast shield designs interact with the lacting breast during pumping. 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?
Soft edge oval - Hard oval - Modified PF breast shield, Modified PF breast shield - Soft edge oval - Hard oval and Hard oval - Soft edge oval - Modified PF breast shield
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSwitzerland
Study dates
Feb 2016to Apr 2016
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

  • Female over 18 years
  • The participant agrees to pump or feed the last time a minimum of 3 hours before the start of the pumping sessions (phase 1)
  • The participant agrees to photograph and video record the breast and upper body (no face) as well as to take audio data.
  • Participant agrees to the presence of up to 3 men in the room during the pumping session
  • The participant has been pumping at least 7 times in the week prior to study participation, no matter which electric pumps.
  • The participant has been consistently pumping 10 ml of milk or more per breast, per pumping session prior to study participation.
  • The participant currently use a breast shield size of 24 mm
  • The participant has agreed to pump at least 7 times a week over the next three weeks

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Medela AG

    Baar, Canton of Zug, 6340

Other trials in Switzerland

About this study

A prospective, randomized, 2-phase/crossover, single center premarket feasibility study. In phase I the comfort will be assessed, the occurence and types of adverse events will be recorded and the assessment how and if the different breast shield designs interact with the lacting breast during pumping. Phase II takes place at home; assessment of adverse events will be recorded and the assessment how the subjects perceives the comfort of the soft edge breast shield during mid term use at home.

Read the detailed description

This is a prospective, randomized, 2 phase/crossover, single center premarket feasibility study enrolling a total of 15 subjects. Follow up visit will be after 14 days.

The study will be divided in two phases.

The objectives of phase 1 are:

  • assessment of Comfort (subjective)
  • occurrence and types of adverse events
  • to assess if and how the different designs (shapes and soft edge) of the three provided breast shields interacts with the lactating breast during pumping, with regards to:
  • The influence of nipple size, diameter and length (measured before pumping)
  • Maximum comfortable vacuum selected by participant (mmHg)
  • Actual vacuum generated in the tunnel of the breast shields in relation to the vacuum level indicator of the breast pump (mmHg)
  • Characteristics of nipple movement in the tunnel during pumping
  • Amount of tissue entering the tunnel at maximum applied vacuum (mm)
  • Amount of tissue entering the tunnel at minimum applied vacuum (mm)
  • Space between breast and shield (mm)

The objectives of phase 2 are

  • to assess how the participants perceive the comfort of the soft-edge breast shield during mid term use at home
  • to assess which adverse events occur

Study procedures - Phase 1 The participant will be invited for a pumping session (3 times 2 minutes of expression) at Medela Headquarters. The CE-marked Freestyle breast pump and its pumpset will be used in the both phases of the study.The participants will be asked to pump 3 times with each of the 3 breast shields in a randomized order. Each pump session (defined as pump start till pump stop) will be short (2 minutes of pumping after milk ejection has occurred), and all three short pumping session will be done on the left side only. All pump session will start with the stimulation mode and change to expression mode as soon as milk flows.

Study procedures - Phase 2 Once the debriefing is finished the participants will be instructed about the Phase 2 (home use) part of the study and its equipment to be used. Study subjects that do not have a Freestyle system in use, a system will be provided. All subjects will be provided with the applicable breast shield types and introduced as well as the new shields will be handed over.

  • the soft-edge breast shield (non CE-marked) and
  • the modified PersonalFit Breast Shield (non CE-marked) This part will start for each participant the day after the phase 1assessment at Medela Headquarters.

Day 1-7 (Evaluation of pumping experience with the modified PersonalFit breast shield) Day 7 (Comfort evaluation of the modified PersonalFit breast shield) Day 8-14 (Evaluation of pumping experience with the soft-edge breast shield) Day 14 (Comfort evaluation of the soft-edge breast shield)

Conditions
Lactation
Being tested
Soft edge oval - Hard oval - Modified PF breast shield, Modified PF breast shield - Soft edge oval - Hard oval, Hard oval - Soft edge oval - Modified PF breast shield
Medical subject headings
Breast Feeding

What participants receive

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

  • Soft edge oval - Hard oval - Modified PF breast shieldDevice

    Also called Group A

    Treatment order:

    1. soft-edge oval breast shield
    2. Hard oval breast shield
    3. modified PersonalFit breast shield

  • Modified PF breast shield - Soft edge oval - Hard ovalDevice

    Also called Group B

    1. modified PersonalFit breast shield
    2. soft-edge oval breast shield
    3. Hard oval breast shield

  • Hard oval - Soft edge oval - Modified PF breast shieldDevice

    Also called Group C

    1. Hard oval breast shield
    2. soft-edge oval breast shield
    3. modified PersonalFit breast shield
Study groups in NCT02719548
Study groupRoleWhat they receive
Breastshield treatment group AExperimentalParticipants will be treated with the following three breast shields: Soft edge oval - Hard oval - Modified PF breast shield Treatment order is described in the corresponding Intervention. Participant will use each breastshield for 2 min after milk ejection.
Receives: Device: Soft edge oval - Hard oval - Modified PF breast shield
Breastshield treatment group BExperimentalParticipants will be treated with the following three breast shields: Modified PF breast shield - Soft edge oval - Hard oval Treatment order is described in the corresponding Intervention. Participant will use each breastshield for 2 min after milk ejection.
Receives: Device: Modified PF breast shield - Soft edge oval - Hard oval
Breastshield treatment group CExperimentalParticipants will be treated with the following three breast shields: Hard oval - Soft edge oval - Modified PF breast shield Treatment order is described in the corresponding Intervention. Participant will use each breastshield for 2 min after milk ejection.
Receives: Device: Hard oval - Soft edge oval - Modified PF breast shield

What is being measured

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

  1. Endpoint Phase 1_Optical analysis via photo: pumping sessions of the nipple and breast will be video recorded from the lateral side view; study set up will be filmed and the audio data taken to document all the information

    During all three short pumping sessions the nipple and breast will be video recorded from the lateral side view. The study set up will be filmed and the audio data taken to document all the information e.g. nipple movement in the tunnel.

    Measured: End of phase I (is defined from the date when moms are coming for Phase I, which takes up to 2 weeks. But the visit itself per mom takes approx. 2hours)

  2. Endpoint Phase 1_Retrospective analysis via Video: by changing the shape of the breast shield the form of the breast shield will better suit and conform to the breast shape

    It is theorized that by changing the shape of the breast shield the form of the breast shield will better suit and conform to the breast shape, improving comfort, reducing any point compression against the skin surface, and supporting freedom of movement of the nipple in the tunnel.

    During all three short pumping sessions the nipple and breast will be video recorded from the lateral side view. The study set up will be filmed and the audio data taken to document all the information e.g. nipple movement in the tunnel.

    Retrospective analysis will be undertaken of the recorded videos. The videos will be analyzed using software for a Desktop Ruler. Characteristics of nipple movement in the tunnel during pumping/Amount of tissue entering the tunnel at max.applied vacuum(mm)/Amount of tissue entering the tunnel at min.applied vacuum(mm)/Space between breast and shield(mm)

    Measured: End of phase I (is defined from the date when moms are coming for Phase I, which takes up to 2 weeks. But the visit itself per mom takes approx. 2hours)

  3. Endpoint Phase 1_ Questionnaire: After pumping with all 3 breast shields participants will be asked questions about comfort perception, handling experience and the sensation per shield.

    After pumping with all 3 breast shields participants will be asked questions about comfort perception, handling experience and the sensation per shield.

    Measured: End of phase I (is defined from the date when moms are coming for Phase I, which takes up to 2 weeks. But the visit itself per mom takes approx. 2hours)

Secondary outcomes (2)

  1. Endpoint Phase 2_Pump log and questionnaires: will be asked to document each breast milk expression in the pump log.A questionnaire needs to be completed by the end of each week for the used breast shield

    Participants will be asked to document each breast milk expression in the pump log. The final entries can be compared for both shields, e.g. comparison of max.vacuum comfort (mmHg); milk outcome in mm.

    A questionnaire needs to be completed by the end of each week for the used breast shield as well.

    Measured: End of phase II (Phase II takes place for 2 weeks at moms home; the end is defined as 4 weeks after end of phase I)

  2. Endpoint Phase 2_Collection of AEs, if any: To assess which adverse events occurred during the home-test by completing the AE form

    • To assess which adverse events occurred during the home-test by completing the AE form

    Measured: End of phase II (Phase II takes place for 2 weeks at moms home; the end is defined as 4 weeks after end of phase I)

Timeline

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

  1. First posted25 Mar 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

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
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02719548
Sponsor's protocol ID
MBF1505
Acronym
BSD
Status last verified
Apr 2016
First submitted
12 Feb 2016
Last updated
10 Feb 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Soft edge oval - Hard oval - Modified PF breast shield, Modified PF breast shield - Soft edge oval - Hard oval and Hard oval - Soft edge oval - Modified PF 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 1 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?

Endpoint Phase 1_Optical analysis via photo: pumping sessions of the nipple and breast will be video recorded from the lateral side view; study set up will be filmed and the audio data taken to document all the information (time frame: End of phase I (is defined from the date when moms are coming for Phase I, which takes up to 2 weeks. But the visit itself per mom takes approx. 2hours)). The study lists 3 primary outcomes in all. 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 NCT02719548.

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.

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