Assessment of Annabella Breast Pump Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Milk Volume collected using the breast pump
研究概览
简要总结
This is an interventional, prospective, randomized, comparative, two-period cross over study to evaluate the performance of Annabella breast pump against a control breast pump.
详细描述
50 women who are 2-5 months post-delivery will be included in the study following appropriate consent. Women will be randomly allocated to two groups for the type of pump used on the first session. Each expression visit will start approximately 3 hours after the end of a regular baby feeding session. Each expression visit will start approximately 3 hours after the end of a regular baby feeding session. During each visit, milk will be expressed once a day from each of the two breasts (left & right). During the 4 first visits (at least 1 day apart) Annabella or the control pump will be used. After at least 3 days washout period, milk will be expressed for additional 4 days, once a day from each of the two breasts, using the other breast pump. An expression session will last until no milk is expressed for 3 min continuously but not for longer than 25 min. Participants will be serving as their own control. Milk will be collected for volume and quality assessment. Maternal comfort at the end of each visit will be assessed using questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Women ≥ 18 years old
- •Women whom are 2-5 months post delivery
- •Lactating women - Breastfeed with no more than formula feeding twice a day and no solid food feeding (which replace breastfeeding) during the study period.
- •Breastfeed or pumping at least 5 times a day
- •Mother to healthy infant born at ≥ 37 weeks of gestation age.
排除标准
- •Woman who consumes under 1,500 kcal/day (on a diet)
- •Report a high mental stress condition and/or depression
- •Use of estrogen oral contraceptives
- •Pregnant women
- •Suffer from chronic diseases that can impact breast feeding
- •Participate in another clinical trial
- •Mothers of babies who may develop feeding difficulties according to the investigator decisions (such as cleft pallet, autism).
- •Woman with Sunken/ flat nipple or inverted nipple. or any other physiological condition that may disturb breast feeding.
- •Woman that declares at time of recruitment that she is unable to extract more than 25ml per breastfeeding (overall from both breast)
结局指标
主要结局
Milk Volume collected using the breast pump
时间窗: immediately after the intervention
Total milk Volume (cc)
次要结局
- Satisfaction Satisfaction questionnaires(immediately after the intervention)