At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-40
SponsorUniversity of Rochester

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Lactating mothers between 20-40 years old at enrollment

pumping no more than one time per day)

All races and ethnicities may enroll

Singleton infant delivered after 37 weeks

Disqualifiers

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 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)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

240 Participants
are grouped into 2 trial groups
Group A: Mothers primarily feeding their baby expressed HM (Express Group)
Group B: Mothers primarily feeding their baby directly at-the-breast (ATB Group)

Trial outcomes

Primary outcomes

1

Infant Sleep Latency

The time to fall asleep after bedtime(minutes)

Time frame
Baseline, 2 months and 4 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator