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

Breastfeeding, Exclusive Clinical Trial

— PUMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03192241
• Other study ID #: 1051735
• Secondary ID: 20170959
• Status: Completed
• Phase: N/A
• Start date: May 17, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: April 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding, Exclusive

Intervention

Other:
• Pump
Intervention is providing mothers with a manual breast pump and instructions for when it could be used.
• Book
Active control intervention is providing mother's with a children's book and information about reading to baby.

Locations

Country	Name	City	State
United States	University of California Medical Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Academic Pediatric Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exclusive breastfeeding at 6 weeks	Infant has had no food or drink other than breast milk in the last 24 hours	6 weeks
Other	Any breastfeeding at 12 weeks	Infant has taken in breast milk in the last 24 hours	12 weeks
Other	Any breastfeeding at 6 weeks	Infant has taken in breast milk in the last 24 hours	6 weeks
Primary	Exclusive breastfeeding at 12 weeks	Infant has had no food or drink other than breast milk in the last 24 hours	12 weeks
Secondary	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
Secondary	Reading to baby at 12 weeks	Did parent read to baby in the last 24 hours & in the last week	12 weeks