Impact of Breast Shield Designs on Dynamics of Breast Pumping
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medela AG
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
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
时间窗: 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)
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.
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
时间窗: 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)
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)
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.
时间窗: 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)
After pumping with all 3 breast shields participants will be asked questions about comfort perception, handling experience and the sensation per shield.
次要结局
- 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))