Transition From Donor Milk: a Feasibility Study

Recruiting now · Not applicable

Conditions studied: Preterm Birth, Nutrition, Healthy

In brief

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.

Key facts

Study ID

NCT06514014

Run by

Augusta University

People needed

20

Starts

2025-05-01

Expected to finish

2027-06-30

Last updated by the study team

2025-08-24

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Greater than 1,250 grams
• At least 28 days of life
• Diet consisting of donor human milk with/without mother's own milk

You may not qualify if…

• Birth weight below the 5th percentile
• History of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder
• Congenital anomalies
• Care team discretion

Where it is running

• Wellstar-MCG — Augusta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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