PUMP (Providing the Underprivileged With Manual Pumps): An RCT (PUMP)
PUMP (Providing the Underprivileged With Manual Pumps): A Randomized Controlled Trial
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.
- 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.
- 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).
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Sacramento、California、美国、95817
- University of California Medical Center
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- WIC-eligibility (income below 185% the federal poverty line)
- liveborn infant
- in the well newborn nursery
- 12-96 hours of age
- infant is breastfeeding
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Pump
Mothers provided with a manual breast pump
|
Intervention is providing mothers with a manual breast pump and instructions for when it could be used.
|
|
有源比较器：book
Mothers provided with a children's book
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Active control intervention is providing mother's with a children's book and information about reading to baby.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Exclusive breastfeeding at 12 weeks
大体时间：12 weeks
|
Infant has had no food or drink other than breast milk in the last 24 hours
|
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Exclusive breastfeeding through 12 weeks
大体时间：12 weeks
|
Infant has had no food or drink other than breast milk in their lifetime as measured at 12 weeks
|
12 weeks
|
|
Reading to baby at 12 weeks
大体时间：12 weeks
|
Did parent read to baby in the last 24 hours & in the last week
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12 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Exclusive breastfeeding at 6 weeks
大体时间：6 weeks
|
Infant has had no food or drink other than breast milk in the last 24 hours
|
6 weeks
|
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Any breastfeeding at 12 weeks
大体时间：12 weeks
|
Infant has taken in breast milk in the last 24 hours
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12 weeks
|
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Any breastfeeding at 6 weeks
大体时间：6 weeks
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Infant has taken in breast milk in the last 24 hours
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6 weeks
|
合作者和调查者
调查人员
- 首席研究员：Laura R Kair, MD、University of California, Davis
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 1051735
- 20170959 (其他标识符：UC Davis)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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