Comparing breast milk feeding methods for infants
At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
This study is testing how different ways of feeding breast milk to babies affect their sleep and gut health, and it's for families who use pumped breast milk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 0 Days to 40 Years |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT06691932 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include lactating mothers aged 20-40 with infants aged 0-1 month who primarily feed either at the breast or with expressed milk.
Not a fit: Patients who are non-English speaking or those who supplement with formula significantly may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of breast milk dynamics, enhancing infant health outcomes for those receiving breast milk.
How similar studies have performed: While this study addresses previously unexplored relationships in breast milk dynamics, similar studies have shown promise in understanding infant nutrition and health outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rochester, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.