Switching preterm infants from donor human milk to preterm formula

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Wellstar-MCG
  Augusta, Georgia, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.