Transition From Donor Milk: a Feasibility Study

August 19, 2025 updated by: Brian Stansfield, Augusta University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Donor Milk
Active Comparator: Preterm Infant Formula
Dietary supplement: Preterm Infant Formula
Transition from donor human milk to preterm infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Velocity
Time Frame: 36 weeks post menstrual age
Weight velocity between birth and 36 weeks post menstrual age
36 weeks post menstrual age
Fat free mass
Time Frame: 36 weeks post menstrual age
Fat free mass at 36 weeks post menstrual age
36 weeks post menstrual age

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Patients with Bronchopulmonary dysplasia
Time Frame: 36 weeks post menstrual age
36 weeks post menstrual age
Number of Patients with Retinopathy of prematurity
Time Frame: 36 weeks post menstrual age
36 weeks post menstrual age
Number of Patients with Sepsis
Time Frame: 36 weeks post menstrual age
36 weeks post menstrual age
Number of Patients with Necrotizing enterocolitis
Time Frame: 36 weeks post menstrual age
36 weeks post menstrual age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 24, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2193903

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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