Impact of Breast Shield Designs on Dynamics of Breast Pumping

NCT02719548 | Completed

• 1 other identifier: MBF1505
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lactation

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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.

  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)

• 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

  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

  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)

Study Arms (3)

Breastshield treatment group A

EXPERIMENTAL

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.

Device: Soft edge oval - Hard oval - Modified PF breast shield

Breastshield treatment group B

EXPERIMENTAL

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.

Device: Modified PF breast shield - Soft edge oval - Hard oval

Breastshield treatment group C

EXPERIMENTAL

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.

Device: Hard oval - Soft edge oval - Modified PF breast shield

Interventions

Soft edge oval - Hard oval - Modified PF breast shield DEVICE

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

Also known as: Group A

Breastshield treatment group A

Modified PF breast shield - Soft edge oval - Hard oval DEVICE

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

Also known as: Group B

Breastshield treatment group B

Hard oval - Soft edge oval - Modified PF breast shield DEVICE

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

Also known as: Group C

Breastshield treatment group C

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- none

Sponsors & Collaborators

• Medela AG: lead

Study Sites (1)

Medela AG

Baar, Canton of Zug, 6340, Switzerland

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Danielle Prime, PhD

  Medela AG, Lättichstrasse 4b, 6340 Baar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: March 25, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 10, 2020

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)