NCT03192241

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. 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.
  2. 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

1.7 years

First QC Date

June 16, 2017

Last Update Submit

April 1, 2019

Conditions

Breastfeeding, Exclusive

Keywords

reading

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Exclusive breastfeeding through 12 weeks

    12 weeks

  • Reading to baby at 12 weeks

    12 weeks

Other Outcomes (3)

  • Exclusive breastfeeding at 6 weeks

    6 weeks

  • Any breastfeeding at 12 weeks

    12 weeks

  • Any breastfeeding at 6 weeks

    6 weeks

Study Arms (2)

Pump

EXPERIMENTAL

Mothers provided with a manual breast pump

Other: Pump

book

ACTIVE COMPARATOR

Mothers provided with a children's book

Other: Book

Interventions

PumpOTHER

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

Pump
BookOTHER

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

book

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • WIC-eligibility (income below 185% the federal poverty line)
  • liveborn infant
  • in the well newborn nursery
  • hours of age
  • infant is breastfeeding

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • 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.

    PMID: 36646639DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Laura R Kair, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Enrollment will be of 60 mother-infant dyads.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 20, 2017

Study Start

May 17, 2017

Primary Completion

January 30, 2019

Study Completion

January 30, 2019

Last Updated

April 3, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)