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

University of Rochester

Status: Not yet enrolling

Conditions: Low Milk Supply

Treatments: Other: Pumping frequency intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07260968

STUDY00011127

Details and patient eligibility

About

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.

Enrollment: 225 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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225 participants in 3 patient groups

Pumping 6-8 times a day (also known as triple-feeding protocol)

Experimental group

Treatment:

Other: Pumping frequency intervention

Pumping 3-4 times a day (lower frequency of pumping)

Experimental group

Treatment:

Other: Pumping frequency intervention

No additional pumping will be recommended (mothers can choose to pump as they desire)

Experimental group

Treatment:

Other: Pumping frequency intervention