PUMP (Providing the Underprivileged With Manual Pumps): An RCT
Study Details
Study Description
Brief Summary
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.
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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.
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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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pump Mothers provided with a manual breast pump |
Other: Pump
Intervention is providing mothers with a manual breast pump and instructions for when it could be used.
|
| Active Comparator: book Mothers provided with a children's book |
Other: Book
Active control intervention is providing mother's with a children's book and information about reading to baby.
|
Outcome Measures
Primary Outcome Measures
- Exclusive breastfeeding at 12 weeks [12 weeks]
Infant has had no food or drink other than breast milk in the last 24 hours
Secondary Outcome Measures
- Exclusive breastfeeding through 12 weeks [12 weeks]
Infant has had no food or drink other than breast milk in their lifetime as measured at 12 weeks
- Reading to baby at 12 weeks [12 weeks]
Did parent read to baby in the last 24 hours & in the last week
Other Outcome Measures
- Exclusive breastfeeding at 6 weeks [6 weeks]
Infant has had no food or drink other than breast milk in the last 24 hours
- Any breastfeeding at 12 weeks [12 weeks]
Infant has taken in breast milk in the last 24 hours
- Any breastfeeding at 6 weeks [6 weeks]
Infant has taken in breast milk in the last 24 hours
Eligibility Criteria
Criteria
Inclusion Criteria:
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WIC-eligibility (income below 185% the federal poverty line)
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liveborn infant
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in the well newborn nursery
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12-96 hours of age
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infant is breastfeeding
Exclusion Criteria:
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maternal age <18 years
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maternal incarceration
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mother does not speak or read in English
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infant is a twin or higher level multiple
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infant has cleft lip and palate or a known syndrome
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California Medical Center | Sacramento | California | United States | 95817 |
Sponsors and Collaborators
- University of California, Davis
- Academic Pediatric Association
Investigators
- Principal Investigator: Laura R Kair, MD, University of California, Davis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1051735
- 20170959