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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Feeding; Exclusive Breastfeeding

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Kaili Widrick, MS; Phone Number: 5852758991; Email: kaili_widrick@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester Medical Center
      • Contact: Kaili Widrick, MS; Phone Number: 5852758991; Email: kaili_widrick@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

240 mother/infant dyads exclusively feeding HM to healthy infants between 1-5 months postpartum: 120 mothers primarily feeding ATB (ATB Group) and 120 mothers predominantly feeding expressed HM (Express Group)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Mothers primarily feeding their baby expressed HM (Express Group)
Mothers primarily feeding their baby directly at-the-breast (ATB Group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant Sleep Latency	The time to fall asleep after bedtime(minutes)	Baseline, 2 months and 4 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding
• Other Study ID Numbers: STUDY00007528; R01HD112363 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No