Breast FeedingBEGINNCT06691932
At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
An observational study of Breast Feeding and Exclusive Breastfeeding, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 40 years
- Conditions the study is for
- Breast Feeding, Exclusive Breastfeeding
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2024to 1 Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 40 years
- All sexes
- Child, Adult
Study population: 240 mother/infant dyads exclusively feeding HM to healthy infants between 1-5 months postpartum: 120 mothers primarily feeding ATB (ATB Group) and 120 mothers predominantly feeding expressed HM (Express Group)
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Kaili Widrick, MS, 5852758991, kaili_widrick@urmc.rochester.edu
About this study
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
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mothers primarily feeding their baby expressed HM (Express Group) | Not described | |
| Mothers primarily feeding their baby directly at-the-breast (ATB Group) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Sleep Latency
The time to fall asleep after bedtime(minutes)
Measured: Baseline, 2 months and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start12 Nov 2024
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Bridget Young, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691932
- Sponsor's protocol ID
- STUDY00007528
- Other IDs
- R01HD112363
- Acronym
- BEGIN
- Status last verified
- Dec 2025
- First submitted
- 13 Nov 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
- ClinicalTrials.gov ID
- NCT06691932
- Acronym / sponsor ID
- BEGIN / STUDY00007528
- Conditions
- Breast Feeding, Exclusive Breastfeeding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mothers primarily feeding their baby expressed HM (Express Group) | – | – |
| Mothers primarily feeding their baby directly at-the-breast (ATB Group) | – | – |
Who may qualify
- Ages
- 0 days to 40 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- 240 mother/infant dyads exclusively feeding HM to healthy infants between 1-5 months postpartum: 120 mothers primarily feeding ATB (ATB Group) and 120 mothers predominantly feeding expressed HM (Express Group)
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Infant Sleep Latency
Time frame: Baseline, 2 months and 4 months
The time to fall asleep after bedtime(minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Feeding and Exclusive Breastfeeding, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaili Widrick, MS (5852758991, Kaili_widrick@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Sleep Latency (time frame: Baseline, 2 months and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.