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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-17

Study Completion Date

2019-01-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Breastfeeding, Exclusive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Enrollment will be of 60 mother-infant dyads.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Pump

Mothers provided with a manual breast pump

Group Type EXPERIMENTAL

Pump

Intervention Type OTHER

Intervention is providing mothers with a manual breast pump and instructions for when it could be used.

book

Mothers provided with a children's book

Group Type ACTIVE_COMPARATOR

Book

Intervention Type OTHER

Active control intervention is providing mother's with a children's book and information about reading to baby.

Interventions

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Pump

Intervention is providing mothers with a manual breast pump and instructions for when it could be used.

Intervention Type OTHER

Book

Active control intervention is providing mother's with a children's book and information about reading to baby.

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No