At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)

NCT ID: NCT06691932

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2029-11-01

Brief Summary

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

Breast Feeding; Exclusive Breastfeeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Mothers primarily feeding their baby expressed HM (Express Group)

No interventions assigned to this group

Mothers primarily feeding their baby directly at-the-breast (ATB Group)

No interventions assigned to this group

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.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Bridget Young

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester Medical Center

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kaili Widrick, MS

Role: CONTACT

Kaili_widrick@urmc.rochester.edu

5852758991

Facility Contacts

Kaili Widrick, MS

Role: primary

kaili_widrick@urmc.rochester.edu

5852758991

Other Identifiers

R01HD112363

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007528

Identifier Type: -

Identifier Source: org_study_id