Clinical trial NCT02719548: Impact of Breast Shield Designs on Dynamics of Breast Pumping
Official title: Impact of Breast Shield Designs on Dynamics of Breast Pumping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactation
Lead sponsor: Medela AG
Sponsor class: INDUSTRY
First posted: 2016-03-25
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

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)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- none

Primary outcomes:
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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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.
timeFrame: 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:
measure: 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
timeFrame: 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)
measure: Endpoint Phase 2_Collection of AEs, if any: To assess which adverse events occurred during the home-test by completing the AE form
timeFrame: 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)
Other outcomes:
Locations:
city: Baar
country: Switzerland
facility: Medela AG
state: Zug
Study officials:
affiliation: Medela AG, Lättichstrasse 4b, 6340 Baar
name: Danielle Prime, PhD
role: PRINCIPAL_INVESTIGATOR
References: