PUMP (Providing the Underprivileged With Manual Pumps): An RCT

Not Applicable

Completed

• Conditions: Breastfeeding, Exclusive
• Interventions: Other: Pump; Other: Book

• Registration Number: NCT03192241
• Lead Sponsor: University of California, Davis

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:

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-17
• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-20
• Primary Completion: 2019-01-30
• Study Completion: 2019-01-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pump	Pump	Mothers provided with a manual breast pump
book	Book	Mothers provided with a children's book

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of California Medical Center; 🇺🇸 Sacramento, California, United States