NCT03091985已完成不适用
Influence of the Brownie Breast Shield on the Dynamics of Milk Removal
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medela AG
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- PAMR
研究概览
简要总结
The purpose of this study is to investigate the efficacy of breast drainage of the healthy breast with the new Medela pump set breast shield (Brownie).
The objective of the study is to verify the Brownie breast shield to be non-inferior to the current PersonalFit breast shield in emptying the healthy lactating breast.
详细描述
In this study we could show that the Brownie shield is non-inferior to the PersonalFit shield in all four endpoints, superior to the PersonalFit shield in terms of PAMR and expressed milk volume, and is more comfortable than the PersonalFit shield according to participant surveys.
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
- Single (Outcomes Assessor)
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
- •Subject ≥ 18 years old
- •Infant is ≥1 and ≤6 month old
- •Subject is predominantly breastfeeding (80% of all feeds, i.e. ≤150 ml formula/day or equal representative amount of solid food)
- •The subject agrees to pump or feed the last time a minimum of 3 hours before the start of the pumping session at the study site
- •The subject agrees to photographs of the breast and upper body (no face)
- •The subject agrees to perform a 24 hour milk production at home, inclusive weighing the Infant before and after each feeding
- •The subject agrees to collect ~2 ml of milk before and after each feeding for fat analysis
- •The subject signed the Informed Consent Form
排除标准
- •Mastitis (any breast within two weeks prior enrolment)
- •Engorgement (any breast within two weeks prior enrolment)
结局指标
主要结局
PAMR
时间窗: 7-21 days
Breast drainage, determined by the metric percent of available milk removed (PAMR).
次要结局
- Milk volume(After 15 minutes of controlled pumping with the test or comparator device. Each participant will pump twice with a "washout period" of 7-21 days in between the corresponding occasions.)
- Mid fat content(After 15 minutes of controlled pumping with the test or comparator device. Each participant will pump twice with a "washout period" of 7-21 days in between the corresponding occasions.)
- Hind fat content(After 15 minutes of controlled pumping with the test or comparator device. Each participant will pump twice with a "washout period" of 7-21 days in between the corresponding occasions.)
- Device usability(After 15 minutes of controlled pumping with the test or comparator device. Each participant will pump twice with a "washout period" of 7-21 days in between the corresponding occasions.)
研究者
研究点 (2)
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