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临床试验/NCT03192241
NCT03192241已完成不适用

PUMP (Providing the Underprivileged With Manual Pumps): A Randomized Controlled Trial

University of California, Davis2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年5月17日最近更新:
适应症

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:

  1. 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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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