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Completed

NCT Number: NCT03192241

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

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Medical Center

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pump

Other

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

Book

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Academic Pediatric Association

Registry information

Official study title

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

Acronym: PUMP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 20, 2017
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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