Switching preterm infants from donor human milk to preterm formula
Transition From Donor Milk: a Feasibility Study
This study will try switching preterm and very low birth weight infants who are at least 28 days old and currently on donor human milk to a preterm infant formula to see if they gain weight and length faster and build more fat-free mass.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 28 Days and up |
| Sex | All |
| Sponsor | Augusta University Academic / other |
| Locations | 1 site (Augusta, Georgia) |
| Trial ID | NCT06514014 on ClinicalTrials.gov |
What this trial studies
This is a single-center interventional feasibility study enrolling preterm infants (>1250 g and ≥28 days old) whose diet is primarily donor human milk. Enrolled infants will be transitioned from donor human milk to a preterm infant formula after the first month of life. Investigators will monitor growth outcomes (weight, length) and body composition (fat-free mass) as well as safety events such as feeding intolerance. The study is conducted at Wellstar-MCG in Augusta, Georgia, under Augusta University sponsorship.
Who should consider this trial
Good fit: Ideal candidates are preterm infants over 1,250 g who are at least 28 days old and currently receiving donor human milk (with or without mother's milk) and who do not have major gastrointestinal disease or congenital anomalies.
Not a fit: Infants with birth weight below the 5th percentile, a history of NEC or intestinal perforation, significant congenital anomalies, or for whom the care team advises against switching may not benefit from this approach.
Why it matters
Potential benefit: If successful, switching to preterm formula after the first month could lead to faster weight and length gains and greater lean mass accumulation while remaining safe.
How similar studies have performed: There are limited clinical data guiding the optimal duration of donor human milk in preterm infants, and while formula feeding can increase short-term growth, this specific transition strategy has not been well tested in prior trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Augusta, Georgia
- Wellstar-MCG — Augusta, Georgia, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.