Recruiting

At-the-Breast vs. Expressed

Sponsor:

University of Rochester

Code:

NCT06691932

Conditions

Breast Feeding

Exclusive Breastfeeding

Eligibility Criteria

Sex: All

Age: 0 - 40

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Breast Feeding

Exclusive Breastfeeding

Study ID

NCT06691932

Start date

Nov 12, 2024

Status verified date

Dec, 2025

Completion date

Nov 1, 2029

Anticipated

Primary completion date

Nov 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 40

Healthy Volunteers: Not accepted

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

Enrollment

240 participants

Anticipated

Interventions and Outcome Measures

Arms

Mothers primarily feeding their baby expressed HM (Express Group)

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 and Locations

Central contacts

Kaili Widrick, MS

5852758991Kaili_widrick@urmc.rochester.edu

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Kaili Widrick, MS

5852758991kaili_widrick@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2025-12-11.