NCT06514014NARecruiting

Transition From Donor Milk: a Feasibility Study

Augusta University

Start Date

5/1/2025

Completion Date

6/30/2027

Summary

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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: 1. Greater than 1,250 grams 2. At least 28 days of life 3. Diet consisting of donor human milk with/without mother's own milk Exclusion Criteria: 1. Birth weight below the 5th percentile 2. History of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder 3. Congenital anomalies 4. Care team discretion

Interventions

DIETARY_SUPPLEMENT

Preterm Infant Formula

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Conditions

Preterm BirthNutrition, Healthy

Locations

Wellstar-MCG

Augusta, Georgia 30912

United States