At-the-Breast Vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
Launched by UNIVERSITY OF ROCHESTER · Nov 13, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The BEGIN study is looking at how breast milk changes over time and how this affects babies' sleep patterns and gut health. Researchers want to understand the differences between babies who feed directly from the breast and those who receive pumped breast milk. This is important because it can help improve feeding practices and health outcomes for all babies who are breastfed.
To participate in this study, mothers need to be between 20 and 40 years old and should primarily breastfeed (at least 75% of the time) either directly or with pumped milk. They can enroll with their healthy babies who are between 0 and 1 month old. The study is currently recruiting participants of all races and ethnicities. Those who join can expect to contribute to important research that could benefit many families, especially those who use pumped milk. It's also important to note that non-English speakers cannot participate, and mothers who mix breastfeeding methods or have certain health complications are not eligible.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Lactating mothers between 20-40 years old at enrollment
- • o 120 mother/infant dyads who primarily feed HM ATB (average \>75% of feeds,
- • pumping no more than one time per day)
- • o 120 mother/infant dyads who predominantly feed expressed HM (average \>75% of feeds)
- • All races and ethnicities may enroll
- • Singleton infant delivered after 37 weeks
- • Infant between the ages of 0-1 months at the time of enrollment.
- • No serious health complications in mother or infant
- Exclusion Criteria:
- • Non-English-speaking subjects as study personnel only speak English
- • Lactating moms who will be feeding both ATB and expressed HM (over 25% of the time in either feeding mode)
- • Infant supplementation with formula ≥10 oz before sample collections begin, and/or no more than 16 oz during active participation/ sample collections.
About University Of Rochester
The University of Rochester is a leading academic institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Renowned for its commitment to excellence in education, research, and clinical practice, the university fosters a collaborative environment that integrates cutting-edge scientific inquiry with practical applications in healthcare. With a focus on diverse therapeutic areas, the University of Rochester aims to enhance treatment options and outcomes for patients while contributing to the broader scientific community through rigorous study design and ethical standards in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, New York, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported