Breastfeeding, ExclusivePUMPNCT03192241
PUMP (Providing the Underprivileged With Manual Pumps): An RCT
A study testing Pump and Book in people with Breastfeeding, Exclusive, run by University of California, Davis at 1 site in United States.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breastfeeding, Exclusive
- What is being tested?
- Pump and Book
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2017to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- WIC-eligibility (income below 185% the federal poverty line)
- liveborn infant
- in the well newborn nursery
- 12-96 hours of age
- infant is breastfeeding
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Medical Center
Sacramento, California, 95817
About this study
Official title: PUMP (Providing the Underprivileged With Manual Pumps): A Randomized Controlled Trial
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).
- Conditions
- Breastfeeding, Exclusive
- Being tested
- Pump, Book
- Keywords
- reading
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PumpOther
Intervention is providing mothers with a manual breast pump and instructions for when it could be used.
BookOther
Active control intervention is providing mother's with a children's book and information about reading to baby.
| Study group | Role | What they receive |
|---|---|---|
| Pump | Experimental | Mothers provided with a manual breast pump Receives: Other: Pump |
| book | Active comparator | Mothers provided with a children's book Receives: Other: Book |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding at 12 weeks
Infant has had no food or drink other than breast milk in the last 24 hours
Measured: 12 weeks
Secondary outcomes (2)
Exclusive breastfeeding through 12 weeks
Infant has had no food or drink other than breast milk in their lifetime as measured at 12 weeks
Measured: 12 weeks
Reading to baby at 12 weeks
Did parent read to baby in the last 24 hours \& in the last week
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start17 May 2017
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrollment will be of 60 mother-infant dyads.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Pediatric Association
- Responsible party
- Sponsor
- Investigators
- Laura R Kair, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192241
- Sponsor's protocol ID
- 1051735
- Other IDs
- 20170959
- Acronym
- PUMP
- Status last verified
- Apr 2019
- First submitted
- 16 Jun 2017
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36646639
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PUMP (Providing the Underprivileged With Manual Pumps): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03192241
- Acronym / sponsor ID
- PUMP / 1051735
- Conditions
- Breastfeeding, Exclusive
- Keywords
- reading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Academic Pediatric Association
- Study start
- 17 May 2017 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Enrollment will be of 60 mother-infant dyads.
| Arm | Type | Receives |
|---|---|---|
| Pump | Experimental | Other: PumpMothers provided with a manual breast pump |
| book | Active comparator | Other: BookMothers provided with a children's book |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- WIC-eligibility (income below 185% the federal poverty line)
- liveborn infant
- in the well newborn nursery
- 12-96 hours of age
- infant is breastfeeding
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PumpIntervention is providing mothers with a manual breast pump and instructions for when it could be used. | Other | Pump |
| BookActive control intervention is providing mother's with a children's book and information about reading to baby. | Other | book |
Primary outcome
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
2 secondary outcomes
Exclusive breastfeeding through 12 weeks
Time frame: 12 weeks
Reading to baby at 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Derived from this study: PubMed 36646639Hoyt-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura R Kair, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pump and Book in people with Breastfeeding, Exclusive, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03192241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.