Low Milk SupplyFLOWNCT07260968
Facilitating Lactation Through Optimized Workflows - Evaluating the Efficiency of Pumping Protocols and Cellular Mechanisms of Milk Production
A study testing Pumping frequency intervention in people with Low Milk Supply, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of two different breast pumping protocols in increasing milk production among lactating individuals diagnosed with primary low milk supply, and to investigate the associated molecular, hormonal, and inflammatory mechanisms driving milk output. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Milk Supply
- What is being tested?
- Pumping frequency intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English-speaking
- Lactating parents of singleton, term infants less than 3 months of age
- Intend to breastfeed and are breastfeeding (at the breast) at least 3 times per day
Who cannot join
- Twins and other multiples
- Contraindications to or unable to breastfeed
- Major congenital anomaly or unexpected surgery
- Elevated maternal depression
- Low milk transfer
- No electricity or smartphone access
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
URMC Breastfeeding & Lactation Clinic
Rochester, New York, 14642
Casey Rosen-Carole, MD, MPH, MSEd, NABBLM-C, FABM, (585) 275-5646, Casey_Rosen-carole@URMC.Rochester.edu
About this study
The purpose of this study is to evaluate the effectiveness of two different breast pumping protocols in increasing milk production among lactating individuals diagnosed with primary low milk supply, and to investigate the associated molecular, hormonal, and inflammatory mechanisms driving milk output.
- Conditions
- Low Milk Supply
- Being tested
- Pumping frequency intervention
- Keywords
- Lactation, Breastfeeding, Triple Feeding, Low milk production, Low milk supply
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pumping frequency interventionOther
In this randomized clinical trial, we will evaluate whether a lower frequency of pumping (3-4 times/day) or no additional pumping recommendations can lead to higher compliance, an increase in milk production, and a longer duration of breastfeeding.
| Study group | Role | What they receive |
|---|---|---|
| Pumping 6-8 times a day (also known as triple-feeding protocol) | Experimental | Not described Receives: Other: Pumping frequency intervention |
| Pumping 3-4 times a day (lower frequency of pumping) | Experimental | Not described Receives: Other: Pumping frequency intervention |
| No additional pumping will be recommended (mothers can choose to pump as they desire) | Placebo comparator | Not described Receives: Other: Pumping frequency intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Milk Production
The study will measure milk production over 24 hours using a 24-hour test weighing (weighing infants before and after each feed) before and after the intervention.
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start7 May 2026
- Primary completion20 Dec 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Milk SupplyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University
- Responsible party
- Principal investigator, Casey Rosen-Carole, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260968
- Sponsor's protocol ID
- STUDY00011127
- Acronym
- FLOW
- Status last verified
- Jun 2026
- First submitted
- 21 Nov 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Lactation Through Optimized Workflows - Evaluating the Efficiency of Pumping Protocols and Cellular Mechanisms of Milk Production
- ClinicalTrials.gov ID
- NCT07260968
- Acronym / sponsor ID
- FLOW / STUDY00011127
- Conditions
- Low Milk Supply
- Keywords
- Lactation, Breastfeeding, Triple Feeding, Low milk production, Low milk supply
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Cornell University
- Study start
- 7 May 2026 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 3 Dec 2025 (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 purpose of this study is to evaluate the effectiveness of two different breast pumping protocols in increasing milk production among lactating individuals diagnosed with primary low milk supply, and to investigate the associated molecular, hormonal, and inflammatory mechanisms driving milk output.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pumping 6-8 times a day (also known as triple-feeding protocol) | Experimental | Other: Pumping frequency intervention |
| Pumping 3-4 times a day (lower frequency of pumping) | Experimental | Other: Pumping frequency intervention |
| No additional pumping will be recommended (mothers can choose to pump as they desire) | Placebo comparator | Other: Pumping frequency intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- English-speaking
- Lactating parents of singleton, term infants less than 3 months of age
- Intend to breastfeed and are breastfeeding (at the breast) at least 3 times per day
Key exclusion criteria (6 listed)
- Twins and other multiples
- Contraindications to or unable to breastfeed
- Major congenital anomaly or unexpected surgery
- Elevated maternal depression
- Low milk transfer
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 |
|---|---|---|
| Pumping frequency interventionIn this randomized clinical trial, we will evaluate whether a lower frequency of pumping (3-4 times/day) or no additional pumping recommendations can lead to higher compliance, an increase in milk production, and a longer duration of breastfeeding. | Other | No additional pumping will be recommended (mothers can choose to pump as they desire), Pumping 3-4 times a day (lower frequency of pumping), Pumping 6-8 times a day (also known as triple-feeding protocol) |
Primary outcome
Milk Production
Time frame: 6 month follow-up
The study will measure milk production over 24 hours using a 24-hour test weighing (weighing infants before and after each feed) before and after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
Related trials for Low Milk Supply
Recruiting
Galactagogue Use in Lactating Women With Low Milk Supply
Breast Milk Expression
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.
URMC Breastfeeding & Lactation Clinic
Rochester, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pumping frequency intervention in people with Low Milk Supply, run by University of Rochester 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Milk Production (time frame: 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2026.