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

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ClinicalTrials.gov Identifier: NCT03192241
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
Academic Pediatric Association
Information provided by (Responsible Party):
University of California, Davis

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).

Condition or disease Intervention/treatment Phase
Breastfeeding, Exclusive Other: Pump Other: Book Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Enrollment will be of 60 mother-infant dyads.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: PUMP (Providing the Underprivileged With Manual Pumps): A Randomized Controlled Trial
Actual Study Start Date : May 17, 2017
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: Pump
Mothers provided with a manual breast pump
Other: Pump
Intervention is providing mothers with a manual breast pump and instructions for when it could be used.

Active Comparator: book
Mothers provided with a children's book
Other: Book
Active control intervention is providing mother's with a children's book and information about reading to baby.




Primary Outcome Measures :
  1. Exclusive breastfeeding at 12 weeks [ Time Frame: 12 weeks ]
    Infant has had no food or drink other than breast milk in the last 24 hours


Secondary Outcome Measures :
  1. Exclusive breastfeeding through 12 weeks [ Time Frame: 12 weeks ]
    Infant has had no food or drink other than breast milk in their lifetime as measured at 12 weeks

  2. Reading to baby at 12 weeks [ Time Frame: 12 weeks ]
    Did parent read to baby in the last 24 hours & in the last week


Other Outcome Measures:
  1. Exclusive breastfeeding at 6 weeks [ Time Frame: 6 weeks ]
    Infant has had no food or drink other than breast milk in the last 24 hours

  2. Any breastfeeding at 12 weeks [ Time Frame: 12 weeks ]
    Infant has taken in breast milk in the last 24 hours

  3. Any breastfeeding at 6 weeks [ Time Frame: 6 weeks ]
    Infant has taken in breast milk in the last 24 hours



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192241


Locations
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United States, California
University of California Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Academic Pediatric Association
Investigators
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Principal Investigator: Laura R Kair, MD University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03192241     History of Changes
Other Study ID Numbers: 1051735
20170959 ( Other Identifier: UC Davis )
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Davis:
reading