RecruitingNot ApplicableNCT06514014
Transition From Donor Milk: a Feasibility Study
Sponsor
Augusta University
Enrollment
20 participants
Start Date
May 1, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 28 Days
Inclusion Criteria3
- Greater than 1,250 grams
- At least 28 days of life
- Diet consisting of donor human milk with/without mother's own milk
Exclusion Criteria4
- Birth weight below the 5th percentile
- History of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder
- Congenital anomalies
- Care team discretion
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Interventions
DIETARY_SUPPLEMENTPreterm Infant Formula
Transition from donor human milk to preterm infant formula
Locations(1)
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NCT06514014
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