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
N/A
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
Researchers are studying human milk as a complex system to understand how it changes over time and throughout the day, how these changes relate to infant sleep and microbiome patterns, and how feeding method (direct breastfeeding versus expressed milk) affects these relationships. This observational study aims to fill important knowledge gaps to better support families feeding pumped breast milk and improve infant feeding and health outcomes. The study compares two groups of mothers and infants: those primarily feeding directly at-the-breast and those primarily feeding expressed human milk. Researchers will collect data over time to model milk dynamics and their links to infant sleep and microbiome. The study focuses on lactating mothers aged 20 to 40 with healthy, full-term singleton infants aged 0 to 1 month at enrollment. Participants will be followed to assess infant sleep latency at baseline, 2 months, and 4 months. The study includes collecting information on feeding patterns, infant sleep, and microbiome dynamics. This will help understand how milk and infant factors interact over time. The total participation duration varies, with ongoing monitoring to capture these dynamic relationships in infant nutrition.
CONDITIONS
Brief 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
- Mothers who primarily feed their baby directly at-the-breast (over 75% of feeds) and pump no more than once per day
- Mothers who primarily feed their baby expressed human milk (over 75% of feeds)
- All races and ethnicities are eligible
- Singleton infant delivered after 37 weeks gestation
- Infant aged 0 to 1 month at enrollment
- No serious health complications in mother or infant
You will not qualify if you...
- Non-English-speaking participants
- Mothers who feed both at-the-breast and expressed milk more than 25% of the time in either mode
- Infants supplemented with formula 10 ounces or more before sample collection or more than 16 ounces during active participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 months
Participants are observed to compare infant sleep latency and feeding methods over time.
3 visits (at baseline, 2 months, and 4 months)
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
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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