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

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.

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Key information

Conditions

Low Milk Supply Behavior Breast Feeding Feeding Behavior

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

URMC Breastfeeding & Lactation Clinic

Rochester, New York, 14642, United States

Location status: Recruiting

Location contact

Casey Rosen-Carole, MD, MPH, MSEd, NABBLM-C, FABM

CONTACT

[email protected]

(585) 275-5646

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pumping frequency intervention

Other

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

Cornell University

Registry information

Acronym: FLOW

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Dec 3, 2025
Registry last updated: Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed