RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-12
Study Completion:2029-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06691932

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Days to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Lactating mothers between 20-40 years old at enrollment
  2. * pumping no more than one time per day)
  3. * All races and ethnicities may enroll
  4. * Singleton infant delivered after 37 weeks
  5. * Infant between the ages of 0-1 months at the time of enrollment.
  6. * No serious health complications in mother or infant
  1. * Non-English-speaking subjects as study personnel only speak English
  2. * Lactating moms who will be feeding both ATB and expressed HM (over 25% of the time in either feeding mode)
  3. * Infant supplementation with formula ≥10 oz before sample collections begin, and/or no more than 16 oz during active participation/ sample collections.

Contacts and Locations

Study Contact

Kaili Widrick, MS
CONTACT
5852758991
Kaili_widrick@urmc.rochester.edu

Study Locations (Sites)

University of Rochester Medical Center
Rochester, New York, 14642
United States

Collaborators and Investigators

Sponsor: University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-12
Study Completion Date2029-11-01

Study Record Updates

Study Start Date2024-11-12
Study Completion Date2029-11-01

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Feeding
  • Exclusive Breastfeeding