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

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT06691932
Status
Recruiting
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Conditions

  • Breast Feeding
  • Exclusive Breastfeeding

Eligibility Criteria

Sex
ALL
Age
0 Days - 40 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Nov 12, 2024
Status verified
Dec 2025
Primary completion
Nov 1, 2029
Completion
Nov 1, 2029

Study Design

Enrollment
240 participants (estimated)

Arms

  • Arm: Mothers primarily feeding their baby expressed HM (Express Group)
  • Arm: Mothers primarily feeding their baby directly at-the-breast (ATB Group)

Primary Outcome Measure

Infant Sleep Latency [ Time Frame: Baseline, 2 months and 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Medical CenterRochesterNew York14642
Kaili Widrick, MS
[email protected]
5852758991

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By research site
University of Rochester Medical Center· Rochester, NY

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