Transition From Donor Milk: a Feasibility Study

Augusta University

Status: Enrolling

Conditions: Nutrition, Healthy; Preterm Birth

Treatments: Dietary Supplement: Preterm Infant Formula

Study type: Interventional

Funder types: Other

Identifiers

NCT06514014

2193903

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 28+ days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Donor Milk

No Intervention group

Preterm Infant Formula

Active Comparator group

Treatment:

Dietary Supplement: Preterm Infant Formula