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Purpose

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

Eligibility

Eligible Ages
Between 0 Days and 40 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

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

Recruiting Locations

University of Rochester Medical Center
Rochester 5134086, New York 5128638 14642
Contact:
Kaili Widrick, MS
5852758991
kaili_widrick@urmc.rochester.edu

More Details

Status
Recruiting
Sponsor
University of Rochester

Study Contact

Kaili Widrick, MS
5852758991
Kaili_widrick@urmc.rochester.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.