PUMP (Providing the Underprivileged With Manual Pumps): A... | NCT03192241

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

NCT03192241

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

Apr 3, 2019Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Breastfeeding, Exclusive

Interventions

Pump
Book

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
20170959	Other Identifier	UC Davis

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 17, 2017Actual

Primary Completion Date

Jan 30, 2019Actual

Completion Date

Jan 30, 2019Actual

First Submitted Date

Jun 16, 2017

First Submission Date that Met QC Criteria

Jun 19, 2017

First Posted Date

Jun 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2019

Last Update Posted Date

Apr 3, 2019Actual

Name	Class
Academic Pediatric Association	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pump	Experimental	Mothers provided with a manual breast pump	Other: Pump
book	Active Comparator	Mothers provided with a children's book	Other: Book

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pump	Other	Intervention is providing mothers with a manual breast pump and instructions for when it could be used.	Pump

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Exclusive breastfeeding at 6 weeks	Infant has had no food or drink other than breast milk in the last 24 hours	6 weeks
Any breastfeeding at 12 weeks	Infant has taken in breast milk in the last 24 hours

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laura R Kair, MD	University of California, Davis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California Medical Center		Sacramento	California	95817	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36646639	Derived	Hoyt-Austin AE, Cheng JH, Moua H, Tancredi DJ, Chantry CJ, Kair LR. Providing Low-Income Women With a Manual Pump: A Pilot Study. Hosp Pediatr. 2023 Feb 1;13(2):115-124. doi: 10.1542/hpeds.2021-006380.

ID	Term
D005247	Feeding Behavior
D001519	Behavior