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
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).
|Condition or disease||Intervention/treatment||Phase|
|Breastfeeding, Exclusive||Other: Pump Other: Book||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|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|
Mothers provided with a manual breast 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
Active control intervention is providing mother's with a children's book and information about reading to baby.
- 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
- 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
- Reading to baby at 12 weeks [ Time Frame: 12 weeks ]Did parent read to baby in the last 24 hours & in the last week
- 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
- Any breastfeeding at 12 weeks [ Time Frame: 12 weeks ]Infant has taken in breast milk in the last 24 hours
- Any breastfeeding at 6 weeks [ Time Frame: 6 weeks ]Infant has taken in breast milk in the last 24 hours
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
|United States, California|
|University of California Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Laura R Kair, MD||University of California, Davis|