Clinical trial NCT03192241: PUMP (Providing the Underprivileged With Manual Pumps): An RCT
Official title: PUMP (Providing the Underprivileged With Manual Pumps): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding, Exclusive
Keywords: reading
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Academic Pediatric Association
First posted: 2017-06-20
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrollment will be of 60 mother-infant dyads.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility criteria: 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

Primary outcomes:
measure: Exclusive breastfeeding at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Exclusive breastfeeding through 12 weeks
timeFrame: 12 weeks
measure: Reading to baby at 12 weeks
timeFrame: 12 weeks
Other outcomes:
measure: Exclusive breastfeeding at 6 weeks
timeFrame: 6 weeks
measure: Any breastfeeding at 12 weeks
timeFrame: 12 weeks
measure: Any breastfeeding at 6 weeks
timeFrame: 6 weeks
Locations:
city: Sacramento
country: United States
facility: University of California Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Laura R Kair, MD
role: PRINCIPAL_INVESTIGATOR
References: