Actively Recruiting

Phase Not Applicable
Age: 28Days +
All Genders
NCT06514014

Transition From Donor Milk: a Feasibility Study

Led by Augusta University · Updated on 2025-08-24

20

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Transition From Donor Milk: a Feasibility Study

Who Can Participate

Age: 28Days +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Baby's birth weight is greater than 1,250 grams
  • Baby is at least 28 days old
  • Baby's diet includes donor human milk with or without mother's own milk
Not Eligible

You will not qualify if you...

  • Baby's birth weight is below the 5th percentile
  • Baby has a history of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder
  • Baby has congenital anomalies
  • Care team discretion excludes participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wellstar-MCG

Augusta, Georgia, United States, 30912

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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