RECRUITING

Transition From Donor Milk: a Feasibility Study

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

Preterm and very low birth weight (VLBW, \< 1,500g) infants who receive donor human milk (DHM) often experience slow postnatal growth and no clinical data is available to guide the duration of DHM for preterm infants. The investigators hypothesize that transitioning from DHM to preterm infant formula after the first month of life is both safe and conveys improved weight and length gains and fat free mass accumulation.

Official Title

Transition From Donor Milk: a Feasibility Study

Quick Facts

Study Start:2025-05-01
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06514014

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:28 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Greater than 1,250 grams
  2. 2. At least 28 days of life
  3. 3. Diet consisting of donor human milk with/without mother's own milk
  1. 1. Birth weight below the 5th percentile
  2. 2. History of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder
  3. 3. Congenital anomalies
  4. 4. Care team discretion

Contacts and Locations

Study Locations (Sites)

Wellstar-MCG
Augusta, Georgia, 30912
United States

Collaborators and Investigators

Sponsor: Augusta University

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 Date2025-05-01
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • newborn
  • human milk

Additional Relevant MeSH Terms

  • Preterm Birth
  • Nutrition, Healthy