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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03192241
Acronym
PUMP
Enrollment
120
Registered
2017-06-20
Start date
2017-05-17
Completion date
2019-01-30
Last updated
2019-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Exclusive

Keywords

reading

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).

Interventions

OTHERPump

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

OTHERBook

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

Sponsors

Academic Pediatric Association
CollaboratorINDUSTRY
University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Enrollment will be of 60 mother-infant dyads.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Exclusive breastfeeding at 12 weeks12 weeksInfant has had no food or drink other than breast milk in the last 24 hours

Secondary

MeasureTime frameDescription
Exclusive breastfeeding through 12 weeks12 weeksInfant has had no food or drink other than breast milk in their lifetime as measured at 12 weeks
Reading to baby at 12 weeks12 weeksDid parent read to baby in the last 24 hours & in the last week

Other

MeasureTime frameDescription
Exclusive breastfeeding at 6 weeks6 weeksInfant has had no food or drink other than breast milk in the last 24 hours
Any breastfeeding at 12 weeks12 weeksInfant has taken in breast milk in the last 24 hours
Any breastfeeding at 6 weeks6 weeksInfant has taken in breast milk in the last 24 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026