Comparing breast milk feeding methods for infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the dynamics of human milk as an ecosystem, focusing on how breast milk changes over time and its relationship with infant sleep patterns and microbiome development. The study will involve 240 mother-infant dyads, split between those feeding directly at the breast and those using expressed milk. By analyzing these dynamics, the research seeks to fill critical public health gaps and provide insights that can optimize infant feeding practices and health outcomes. The findings will be particularly beneficial for families who primarily use pumped breast milk.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Rochester Medical Center
  Rochester, New York, United States Recruiting

Study contacts

• Study coordinator: Kaili Widrick, MS
• Email: Kaili_widrick@urmc.rochester.edu
• Phone: 5852758991

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.