At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Feeding, Exclusive Breastfeeding. Basic parameters: 0 Days — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Infant Sleep Latency [Time frame: Baseline, 2 months and 4 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Rochester Medical Center — Rochester
Identifiers
NCT: NCT06691932 · STUDY00007528 · R01HD112363