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

Conditions

• Low Milk Supply

Eligibility Criteria

Sex

ALL

Age

18 Years - 45 Years

Healthy Volunteers

Accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

May 7, 2026

Status verified

Jun 2026

Primary completion

Dec 20, 2027

Completion

Sep 30, 2028

Study Design

Enrollment

225 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pumping 6-8 times a day (also known as triple-feeding protocol)
• Experimental: Pumping 3-4 times a day (lower frequency of pumping)
• Placebo Comparator: No additional pumping will be recommended (mothers can choose to pump as they desire)

Primary Outcome Measure

Milk Production [ Time Frame: 6 month follow-up ]

Locations (1)

Find similar trials in Rochester, NY