NCT06691932 At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
| NCT ID | NCT06691932 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester |
| Condition | Breast Feeding |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-11-12 |
| Primary Completion | 2029-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2024-11-12 with a primary completion date of 2029-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06691932 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 40 Years, studying Breast Feeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06691932 currently recruiting?
Yes, NCT06691932 is actively recruiting participants. Contact the research team at Kaili_widrick@urmc.rochester.edu for enrollment information.
Where is the NCT06691932 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06691932 clinical trial?
NCT06691932 is sponsored by University of Rochester. The trial plans to enroll 240 participants.