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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06691932

Acronym

BEGIN

Enrollment

240

Registered

2024-11-18

Start date

2024-11-12

Completion date

2029-11-01

Last updated

2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding, Exclusive Breastfeeding

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Days to 40 Years

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.

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactKaili Widrick, MS

Kaili_widrick@urmc.rochester.edu5852758991

Outcome results