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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
Treatment order: 1. soft-edge oval breast shield 2. Hard oval breast shield 3. modified PersonalFit breast shield
1. modified PersonalFit breast shield 2. soft-edge oval breast shield 3. Hard oval breast shield
1. Hard oval breast shield 2. soft-edge oval breast shield 3. modified PersonalFit breast shield
Medela AG
Baar, Canton of Zug, Switzerland
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.
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)
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)
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)
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.
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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)
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
Time frame: 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)