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:

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).

Study Overview

• Status: Completed
• Conditions: Breastfeeding, Exclusive
• Intervention / Treatment: Other: Pump; Other: Book

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exclusive breastfeeding at 12 weeks	Infant has had no food or drink other than breast milk in the last 24 hours	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exclusive breastfeeding through 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	Did parent read to baby in the last 24 hours & in the last week	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exclusive breastfeeding at 6 weeks	Infant has had no food or drink other than breast milk in the last 24 hours	6 weeks
Any breastfeeding at 12 weeks	Infant has taken in breast milk in the last 24 hours	12 weeks
Any breastfeeding at 6 weeks	Infant has taken in breast milk in the last 24 hours	6 weeks

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Academic Pediatric Association
• Investigators: Principal Investigator: Laura R Kair, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): January 30, 2019
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: reading
• Other Study ID Numbers: 1051735; 20170959 (Other Identifier: UC Davis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No