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

Study Overview
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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: 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. 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. 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).

Official Title
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PUMP (Providing the Underprivileged With Manual Pumps): A Randomized Controlled Trial

Conditions
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Breastfeeding, Exclusive

Intervention / Treatment
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* Other: Pump
* Other: Book


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Enrollment will be of 60 mother-infant dyads.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pump<br>Mothers provided with a manual breast pump | Other: Pump<br>* Intervention is providing mothers with a manual breast pump and instructions for when it could be used.<br>|
| Active Comparator: book<br>Mothers provided with a children's book | Other: Book<br>* Active control intervention is providing mother's with a children's book and information about reading to baby.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reading