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Facilitating Lactation Through Optimized Workflows - Evaluating the Efficiency of Pumping Protocols and Cellular Mechanisms of Milk Production

Facilitating Lactation Through Optimized Workflows - Evaluating the Efficiency of Pumping Protocols and Cellular Mechanisms of Milk Production

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07260968
Acronym
FLOW
Enrollment
225
Registered
2025-12-03
Start date
2026-05-07
Completion date
2028-09-30
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Milk Supply

Keywords

Lactation, Breastfeeding, Triple Feeding, Low milk production, Low milk supply

Brief 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.

Interventions

OTHERPumping frequency intervention

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.

Sponsors

University of Rochester
Lead SponsorOTHER
Cornell University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Milk Production6 month follow-upThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026