Recruiting NCT07260968
Facilitating Lactation Through Optimized Workflows - Evaluating the Efficiency of Pumping Protocols and Cellular Mechanisms of Milk Production
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pumping frequency intervention.
- Who it may be relevant to
- Registry conditions: Low Milk Supply. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Milk Production [Time frame: 6 month follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- URMC Breastfeeding & Lactation Clinic — Rochester
Identifiers
NCT: NCT07260968 · STUDY00011127