Assessing the Feasibility of Testing Domperidone's Effect on Breastfeeding in Women With Insufficient Breast Milk: An RCT Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- success of continuing breastfeeding
研究概览
简要总结
This study is testing if a medication called domperidone will help women produce more milk so that they can keep breastfeeding and not use formula. The study is also testing what dose of domperidone works best to increase breast milk production.
详细描述
Breastfeeding alone, until an infant is 6 months of age, is the best form of infant nutrition. There are many ways to help women breastfeed when they are having difficulties with the process, mostly involving support from a lactation consultant. However, some women, despite all appropriate non-medical interventions and support do not produce sufficient breast milk to meet the nutritional needs of their infant.
This is a feasibility study to determine how domperidone affects breast milk production in women with insufficient milk supply feeding term infants. This project will serve to refine and advance the design of a subsequent full-scale clinical trial.
The goal of this study is to: a) refine the intervention strategy (drug dosage), b) to define the target population and ensure adequate enrollment, c) assess protocol adherence and subject retention, and d) collect preliminary data to establish measures of clinical efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy women
- •inadequate milk supply
- •read/speak English
- •healthy term infants (≥ 38 weeks gestational age)
- •age ≥ 2wks and ≤3mths
- •surpassed birth weight
排除标准
- •cardiac anomalies
- •breast or endocrine abnormalities (i.e. breast CA, pituitary adenomas)
- •medications contraindicated with domperidone use
- •drug or alcohol use
- •use of hormonal contraception
- •physical anomalies making breastfeeding difficult (i.e. cleft palate)
- •cardiac anomalies
结局指标
主要结局
success of continuing breastfeeding
amount of supplementation used
次要结局
- concentration of domperidone in milk
- concentration of domperidone and prolactin in milk
- maternal satisfaction
- protocol adherence and barriers