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

University of California (UC) Davis

Status: Completed

Conditions: Breastfeeding, Exclusive

Treatments: Other: Book; Other: Pump

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03192241

20170959 (Other Identifier)

1051735

Details and patient eligibility

About

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).

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups

Pump

Experimental group

Description:

Mothers provided with a manual breast pump

Treatment:

Other: Pump

book

Active Comparator group

Description:

Mothers provided with a children's book

Treatment:

Other: Book