NCT07260968

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Sep 2028

First Submitted

Initial submission to the registry

November 21, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

November 21, 2025

Last Update Submit

March 18, 2026

Conditions

Low Milk Supply

Keywords

LactationBreastfeedingTriple FeedingLow milk productionLow milk supply

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 month follow-up

Study Arms (3)

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

Interventions

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.

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)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

URMC Breastfeeding & Lactation Clinic

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MPH, MSEd, NABBLM-C, FABM

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 3, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

December 20, 2027

Study Completion (Estimated)

September 30, 2028

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

US(1)