Impact of Breast Shield Designs on Dynamics of Breast Pumping

NCT ID: NCT02719548

Last Updated: 2020-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-04-30

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)

Conditions

Lactation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Breastshield treatment group A

Participants 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.

Group Type: EXPERIMENTAL

Soft edge oval - Hard oval - Modified PF breast shield

Intervention Type: DEVICE

Treatment order:

1. soft-edge oval breast shield

2. Hard oval breast shield

3. modified PersonalFit breast shield

Breastshield treatment group B

Participants 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.

Group Type: EXPERIMENTAL

Modified PF breast shield - Soft edge oval - Hard oval

Intervention Type: DEVICE

1. modified PersonalFit breast shield

2. soft-edge oval breast shield

3. Hard oval breast shield

Breastshield treatment group C

Participants 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.

Group Type: EXPERIMENTAL

Hard oval - Soft edge oval - Modified PF breast shield

Intervention Type: DEVICE

1. Hard oval breast shield

2. soft-edge oval breast shield

3. modified PersonalFit breast shield

Interventions

Soft edge oval - Hard oval - Modified PF breast shield

Treatment order:

1. soft-edge oval breast shield

2. Hard oval breast shield

3. modified PersonalFit breast shield

Intervention Type: DEVICE

Modified PF breast shield - Soft edge oval - Hard oval

1. modified PersonalFit breast shield

2. soft-edge oval breast shield

3. Hard oval breast shield

Intervention Type: DEVICE

Hard oval - Soft edge oval - Modified PF breast shield

1. Hard oval breast shield

2. soft-edge oval breast shield

3. modified PersonalFit breast shield

Intervention Type: DEVICE

Other Intervention Names

Group A; Group B; Group C

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medela AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Prime, PhD

Role: PRINCIPAL_INVESTIGATOR

Medela AG, Lättichstrasse 4b, 6340 Baar

Locations

Medela AG

Baar, Canton of Zug, Switzerland

Countries

Switzerland

Other Identifiers

MBF1505

Identifier Type: -

Identifier Source: org_study_id