Randomised Trial Comparing the Efficacy of the ISIS Duo iQ Electric Breast Pump and the Medela Symphony Electric Breast Pump in Mothers Expressing Breast Milk for Preterm Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Time taken for first milk to appear.
研究概览
简要总结
This is a randomised controlled trial investigating the performance of two, 'state of the art' electric breast pumps in mothers who have delivered preterm infants. The main data collection period will be up to day 10 post delivery data. Data collected will include a record of the weight of milk produced during the first 10 days and a short questionnaire to find the mothers' opinions of the pumps used. On Day 5 a timed and weighed expression of 15 minutes will be carried out. After the first 10 days, mothers will be asked to collect brief information on their continuing use of their pumps and subsequent duration of breast and bottle feeding, mothers will be contacted at 3 and 6 months post-term
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mothers who have delivered, preterm (before 34 weeks) infants who plan to express breast milk for their infant(s). Their infants will need to be less than 72 hours old prior to enrolment and likely to remain in NICUs for at least 10 days.
排除标准
- •Other mothers not fitting inclusion criteria.
结局指标
主要结局
Time taken for first milk to appear.
时间窗: 10 days post-partum
Total weight of milk expressed during the first 10 days post-partum.
时间窗: 10 days post-partum
Weight of milk collected at 1 minute intervals over a 15 minute period on Day 5.
时间窗: 10 days post-partum
Time taken to express a fixed volume of milk.
时间窗: 10 days post-partum
次要结局
- Mothers' opinions of the assigned pumps on Day 10.(1 day)
- Total number of pumping sessions to Day 10.(10 days)
- Total time spent expressing to Day 10.(10 days)
- Number of days taken to reach full enteral feeds.(10 or more days)
- Volume of milk expressed whilst on neonatal unit.(10 days)