Actively Recruiting
At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
Led by University of Rochester · Updated on 2025-12-11
240
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
Sponsors
U
University of Rochester
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to define human milk (HM) as an ecosystem which investigators will then combine into temporal models of milk dynamics to accurately describe HM chronobiology. This study addresses 4 crucial public health gaps: 1) how breast milk changes over time and over the day, 2) how milk dynamics are related to infant sleep patterns, 3) how milk dynamics are related to infant microbiome dynamics, and 4) how all these relationships differ between infants fed directly at-the-breast vs pumped milk. These fundamental insights have been unknown until now, so that families who feed pumped breast milk are completely underserved. These results are critical to optimizing infant feeding and health outcomes for all infants receiving breast milk.
CONDITIONS
Official Title
At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Lactating mothers between 20 and 40 years old at enrollment
- 120 mother/infant pairs who primarily feed human milk at the breast (over 75% of feeds, pumping no more than once per day)
- 120 mother/infant pairs who predominantly feed expressed human milk (over 75% of feeds)
- All races and ethnicities are eligible
- Singleton infant born after 37 weeks gestation
- Infant between 0 and 1 month old at enrollment
- No serious health problems in mother or infant
You will not qualify if you...
- Non-English-speaking participants (study staff speak only English)
- Mothers who feed both at the breast and expressed milk more than 25% of the time
- Infants supplemented with 10 ounces or more of formula before sample collection or more than 16 ounces during study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
K
Kaili Widrick, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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