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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Twins and other multiples

Contraindications to or unable to breastfeed

Major congenital anomaly or unexpected surgery

Elevated maternal depression

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pumping frequency intervention

    Other 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.

Treatment groups

225 Participants
are divided into 3 treatment groups
Group A: Pumping 6-8 times a day (also known as triple-feeding protocol)Experimental treatment 1 intervention
Group B: Pumping 3-4 times a day (lower frequency of pumping)Experimental treatment 1 intervention
Group C: No additional pumping will be recommended (mothers can choose to pump as they desire)Placebo comparator 1 intervention

Trial outcomes

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.

Time frame
6 month follow-up

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Rochester

Lead sponsor

Cornell University

Collaborator