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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

URMC Breastfeeding & Lactation Clinic
Rochester, New York 14642
Contact:
Casey Rosen-Carole, MD, MPH, MSEd, NABBLM-C, FABM
(585) 275-5646
Casey_Rosen-carole@URMC.Rochester.edu

More Details

Status
Recruiting
Sponsor
University of Rochester

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.