PUMP (Providing the Underprivileged With Manual Pumps): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Exclusive breastfeeding at 12 weeks
研究概览
简要总结
The primary objective of this study is to pilot an intervention of providing manual breast pumps at hospital discharge to low-income, first-time mothers and to generate initial estimates of the effect of this intervention on exclusive breastfeeding rates at 3 months (12 weeks). In this pilot study, we will compare receipt of a breast pump and brief instructions of its use to the active control of receipt of a children's book and brief instructions about reading with baby. As a secondary objective, we will investigate mothers' attitudes and opinions about the manual breast pump intervention with the goal of fine-tuning it to best fit mothers' needs before a larger, multi-center trial. To support our objectives, we will examine the following specific aims:
- To test the intervention of providing low-income, first time mothers with a manual breast pump at hospital discharge on exclusive breastfeeding rates at 12 weeks.
Hypothesis: Among low-income first-time mothers, receipt of a manual breast pump at hospital discharge will lead to improved exclusive breastfeeding rates at 12 weeks postpartum compared to receipt of a children's book. 2. To use qualitative methods to determine best practices associated with successful implementation of a breast pump intervention to improve breastfeeding rates among low-income, first-time mothers. 3. To test the effect of receiving a children's board book during the birth hospitalization on parents reading to the baby at 3 months (12 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •WIC-eligibility (income below 185% the federal poverty line)
- •liveborn infant
- •in the well newborn nursery
- •12-96 hours of age
- •infant is breastfeeding
排除标准
- •maternal age <18 years
- •maternal incarceration
- •mother does not speak or read in English
- •infant is a twin or higher level multiple
- •infant has cleft lip and palate or a known syndrome
结局指标
主要结局
Exclusive breastfeeding at 12 weeks
时间窗: 12 weeks
Infant has had no food or drink other than breast milk in the last 24 hours
次要结局
- Exclusive breastfeeding through 12 weeks(12 weeks)
- Reading to baby at 12 weeks(12 weeks)
