NCT06514014RecruitingNot Applicable
Transition From Donor Milk: a Feasibility Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Augusta University
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Weight Velocity
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 28 Days to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Greater than 1,250 grams
- •At least 28 days of life
- •Diet consisting of donor human milk with/without mother's own milk
Exclusion Criteria
- •Birth weight below the 5th percentile
- •History of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder
- •Congenital anomalies
- •Care team discretion
Outcomes
Primary Outcomes
Weight Velocity
Time Frame: 36 weeks post menstrual age
Weight velocity between birth and 36 weeks post menstrual age
Fat free mass
Time Frame: 36 weeks post menstrual age
Fat free mass at 36 weeks post menstrual age
Secondary Outcomes
- Number of Patients with Bronchopulmonary dysplasia(36 weeks post menstrual age)
- Number of Patients with Retinopathy of prematurity(36 weeks post menstrual age)
- Number of Patients with Sepsis(36 weeks post menstrual age)
- Number of Patients with Necrotizing enterocolitis(36 weeks post menstrual age)
Investigators
Brian Stansfield
Professor and Vice Chair for Research
Augusta University
Study Sites (2)
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