Recruiting

Breast Pumping Protocols

Sponsor:

University of Rochester

Code:

NCT07260968

Conditions

Low Milk Supply

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Pumping frequency intervention

Study Details

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.

Conditions

Low Milk Supply

Study ID

NCT07260968

Start date

May 7, 2026

Status verified date

Jun, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Dec 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

Pumping 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.

Primary outcome measure

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

Central Contacts and Locations

Locations

URMC Breastfeeding & Lactation Clinic

Recruiting

Rochester, New York, United States, 14642

Contacts

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

(585) 275-5646Casey_Rosen-carole@URMC.Rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-06-04.